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Open Clinical Trials

Summer 2007


Below is a list of selected currently enrolling clinical trials gathered from various sources. TrialSearch, operated by the AIDS Community Research Initiative of America (ACRIA), is an extensive online database of clinical trials related to HIV/AIDS.

The federal government's AIDSinfo Web site includes a clinical trials section that features an introduction to HIV/AIDS research and study listings from the National Institutes of Health's ClinicalTrials.gov database. AIDSinfo also offers personalized advice about clinical trial participation via email (ContactUs@AIDSinfo.nih.gov), an interactive Web site (www.aidsinfo.nih.gov/live_help; specialists available Mon.-Fri. 9:00 am-1:00 pm PT), and a toll-free telephone service (800-874-2572, international 301-874-2572; specialists available Mon.-Fri. 9:00 am-2:00 pm PT). CenterWatch is a commercial Web site that includes trial listings for many diseases, including HIV/AIDS and related conditions.

Most U.S. government-sponsored HIV/AIDS trials are conducted by the adult and pediatric AIDS Clinical Trials Group (ACTG). The National Center for Complementary and Alternative Medicine (NCCAM) conducts trials of complementary therapies for conditions related to HIV and its management. The HIV Vaccine Trials Network (HVTN) is an international collaboration testing preventive vaccines.

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Call the telephone numbers listed for each study or see the indicated Web sites for more information about specific trials. Protocol numbers, if available, are provided in parentheses at the end of each trial description. ACRIA TrialSearch: www.acria.org/clinical_trials/index.html

ACTG: www.aactg.org
AIDSInfo: www.aidsinfo.nih.gov
CenterWatch: www.centerwatch.com
ClinicalTrials.gov: www.clinicaltrials.gov
HVTN: www.hvtn.org
NCCAM: www.nccam.nih.gov/clinicaltrials


SPRING Study of Tipranavir

Boehringer Ingelheim recently started enrollment in the SPRING study, an open-label Phase III trial evaluating the safety and efficacy of ritonavir-boosted tipranavir (Aptivus) in a racially diverse population of heavily treatment-experienced individuals, half of them women. The study will also gather pharmacokinetic data and assess the utility of therapeutic drug monitoring (TDM).

"Studies have indicated that the efficacy of antiretroviral treatments may vary across races and genders," said SPRING Coordinating Investigator Kathleen Squires, MD. "Therefore, SPRING is designed to provide insight into potential treatment differences for patient populations such as women and ethnic groups."

All enrolled subjects will begin receiving the standard dose of 500 mg tipranavir plus 200 mg ritonavir (Norvir) twice daily; half the participants will be randomly assigned to undergo TDM, and may then have their doses adjusted as indicated.

Eligible participants must be at least 18 years of age and have used all three major classes of approved antiretroviral drugs for at least three months each. In addition, they must have documented resistance to more than one protease inhibitor (PI). However, subjects must still be able to construct a viable background regimen using approved nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), enfuvirtide (Fuzeon; T-20), and/or investigational agents. Exclusion criteria include prior tipranavir use, genotypic resistance to tipranavir, and a history of treatment interruptions of seven days or longer within the past month. Women may not be pregnant or breast-feeding and must agree to use specified methods of contraception.

The SPRING study aims to enroll 400 participants at more than 72 centers in eight countries. There are about 20 sites in the United States, including Akron, Austin, Cincinnati, Decatur, Ft. Lauderdale, Houston, Jacksonville, Kansas City, Macon, New York City, Norfolk, Oklahoma City, Orlando, Philadelphia, Sacramento, Tampa, and Washington, DC. For details and other study sites, email the Boehringer Ingelheim Study Coordinator at clintriage@rdg.boehringer-ingelheim.com. www.clinicaltrials.gov/show/NCT00440271 (1182.98).


GRACE: Gender Differences in Response to Darunavir

Tibotec's non-peptide PI darunavir (Prezista; formerly TMC114) was approved in June 2006 for use by treatment-experienced patients. The company has started an open-label Phase IIIb trial called GRACE (Gender, Race and Clinical Experience), which will study sex- and race-related differences in the drug's efficacy and tolerability.

While HIV treatment trials have historically included mostly men, GRACE will enroll 70% women. "Women who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women," said treatment advocate Dawn Averitt-Bridge.

All subjects will receive 300 mg darunavir boosted with 100 mg ritonavir twice daily plus optimized background therapy for 48 weeks. Follow-up visits will take place at weeks 4, 8, 12, 16, 24, 36, 48, and 52.

Eligible participants must be at least 18 years of age, have a viral load of at least 1000 copies/mL, and have experienced intolerance or treatment failure on previous regimens containing PIs or non-nucleoside reverse transcriptase inhibitors (NNRTIs). Exclusion criteria include active opportunistic illnesses (OIs), abnormal laboratory test results, and use of certain other medications. Women may not be pregnant or breast-feeding.

The GRACE trial expects to enroll 420 subjects at some 50 sites in the U.S., Canada, and Mexico, including Atlanta, Baltimore, Birmingham, Boston, Chicago, Dallas, Durham, Ft. Lauderdale, Los Angeles, Miami, Nashville, Newark, New Orleans, New York City, Philadelphia, Salt Lake City, Seattle, St. Louis, and Washington, DC. For further information, call 866-512-7943 or email GRACEstudy@wilm.ppdi.com. www.clinicaltrials.gov/show/NCT00381303 (CR011869).


Switching from PIs to Raltegravir

Raltegravir (Isentress; formerly MK-0518), the first CCR5 antagonist, is expected to be approved this year. Merck is conducting two studies to assess the efficacy, safety, and tolerability of the new drug in subjects switching from PI-based regimens.

Both Phase III studies will evaluate the safety and antiviral activity of raltegravir in patients switching from regimens containing lopinavir/ritonavir (Kaletra). HIV RNA, CD4 cell counts, and tolerability will be assessed at weeks 24 and 48, and lipid changes will be measured at weeks 12, 24, and 48.

Eligible participants must be at least 18 years of age and have maintained an undetectable HIV viral load (below 50 copies/mL) for at least three months while on a stable lopinavir/ritonavir-based regimen. Exclusion criteria include acute hepatitis and use of certain other medications, including d4T (stavudine; Zerit), other investigational antiretroviral agents, or lipid-lowering medications. Women may not be pregnant or breast-feeding.

The studies will enroll 340 subjects each at about ten sites in the U.S. (and others in Australia, Canada, Europe, and Mexico), including Birmingham, Chicago, Houston, Newark, New Orleans, Orlando, Vero Beach, and Washington, DC. For further information about either study, call 888-577-8839. www.clinicaltrials.gov/show/NCT00443703 and www.clinicaltrials.gov/show/NCT00443729 (2007_507 and 2007_508).


Racivir vs 3TC in Treatment-Experienced Individuals

Racivir is an experimental NRTI undergoing Phase II testing. Since it is a cytidine analog, Pharmasset is conducting a study to determine how well the drug will work in patients who have developed resistance to another drug of this type, 3TC (lamivudine; Epivir).

Participants currently on failing antiretroviral regimens will be randomly assigned to receive racivir alone, 3TC alone, or racivir plus 3TC once daily for 14-28 days; those with a favorable response at that point may continue on open-label racivir for up to 20 weeks.

Eligible participants must be 18-65 years of age and have been on a stable HAART regimen including 3TC, but not emtricitabine (Emtriva; FTC), for at least 60 days (subjects will stop taking 3TC before they start the study drugs). In addition, they must have HIV with the M184V mutation. Exclusion criteria include current or recent OIs, acute hepatitis B or C, certain laboratory abnormalities, other drug-resistance mutations (Q151M or T69S), and use of certain medications, including other investigational agents. Women may not be pregnant or breast-feeding and must agree to use contraception.

The study will enroll 60 subjects at about ten sites in the U.S. and Latin America, including the Bronx (718-918-3662), Chicago (312-695-4997), and Columbia, SC (803-787-1113). www.clinicaltrials.gov/show/NCT00121979 (CI-PSI-RCV-04-201).


Treatment During Early Infection

While some experts believe antiretroviral therapy should be started soon after HIV infection, it is not yet clear whether treatment of recently infected individuals leads to long-term benefit or harm (see News Briefs, in this issue). In this open-label study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID), participants newly infected with HIV will be randomly assigned to receive either no treatment or a regimen of emtricitabine/tenofovir (Truvada) plus lopinavir/ritonavir for 36 weeks; after 36 weeks, subjects in both arms will have the option to continue or start treatment if they have high viral load, low CD4 count, or HIV-related symptoms. HIV viral load will be measured at the end of treatment and at 72 and 96 weeks to determine whether early therapy appears to lower the viral "set point"; CD4 cell count, occurrence of AIDS-defining illnesses, adverse side effects, and drug resistance will also be assessed. Study visits will occur every 2-4 weeks for the duration of the 96-week trial.

Eligible participants must be at least 18 years of age. They must be recently infected with HIV and have a viral load of at least 500 copies/mL and a CD4 cell count of at least 350 cells/mm3 within 21 days prior to study entry. Exclusion criteria include various medical conditions and use of certain medications (including prior antiretroviral therapy or investigational HIV vaccines). Women may not be pregnant or breastfeeding.

This study aims to enroll 150 volunteers at more than 30 sites, including Atlanta (404-616-6313), Boston (617-724-0070), Chapel Hill (919-843-8761), Denver (303-372-5535), Detroit (313-916-2570), Durham (919-684-8216), Indianapolis (317-274-8456), New York City (212-327-7281), Philadelphia (215-349-8092), Providence (401-793-4396), Rochester (585-275-2740), San Diego (619-543-8080), San Francisco (415-476-9296 ext. 318), Seattle (206-731-8877), and St. Louis (314-454-0058). www.clinicaltrials.gov/ct/show/NCT00090779 (ACTG A5217; AIEDRP AIN503).

Subjects in this trial will also be encouraged to join AIEDRP CORE01, a long-term follow-up study of HIV-positive individuals identified during early infection www.clinicaltrials.gov/ct/show/NCT00086372 (ACTG A5228; AIEDRP CORE01).


First-Line Antiretroviral Regimens

ACTG A5202 is a Phase IIIb study sponsored by NIAID that will compare four antiretroviral regimens in individuals starting therapy for the first time. Participants will be randomly assigned to one of four treatment arms:

  • efavirenz (Sustiva) plus tenofovir/emtricitabine

  • efavirenz plus abacavir/3TC (Epzicom combination pill)

  • ritonavir-boosted atazanavir (Reyataz) plus tenofovir/emtricitabine

  • ritonavir-boosted atazanavir plus abacavir/3TC

Treatment will continue for 96 weeks. Participants will undergo regular monitoring of HIV viral load, CD4 cell count, and blood lipid levels, and will complete questionnaires to assess adherence. Some participants will be asked to participate in a metabolic substudy (ACTG A5224s).

Eligible subjects must be at least 16 years of age; those with recent HIV infection will receive drug-resistance testing. Participants must not have received prior antiretroviral viral therapy for more than seven days total (excluding post-exposure prophylaxis). They must have a viral load greater than 1000 copies/mL within 90 days of study entry; there are no CD4 cell count restrictions. Exclusion criteria include major drug-resistance mutations, various medical conditions (including heart rhythm disturbances), and use of certain medications (including immunomodulators and other investigational agents). Women may not be pregnant or breast-feeding and must agree to use contraception.

This study aims to enroll 1800 participants at more than 60 sites, including Atlanta (404-616-6313), Baltimore (410-614-2766), Birmingham (205-975-7925), Boston (617-414-7082), Chapel Hill (919-843-8761), Chicago (312-572-4545), Cincinnati (513-584-8373), Dallas (214-590-0414), Denver (303-372-5535), Galveston (409-747-0219), Honolulu (808-737-2751), Indianapolis (317-274-8456), Los Angeles (310-557-2273), Miami (305-243-3838), Minneapolis (612-347-2690), Nashville (615-467-0154 ext. 108), Omaha (402-559-8163), New York City (212-746-4393), Philadelphia (215-349-8092), Providence (401-793-4396), Rochester (585-275-2740), Sacramento (916-914-6263), San Diego (619-543-8080), San Francisco (415-514-0550 ext. 354), San Juan (787-759-9595), Seattle (206-731-8877), Stanford (650-723-2804), St. Louis (314-454-0058), and Washington, DC (202-687-2294). www.clinicaltrials.gov/ct/show/NCT00118898 (ACTG A5202).


INCB9471: Once-Daily Oral CCR5 Inhibitor

Incyte Corporation is sponsoring a Phase II trial to assess the safety, pharmacokinetics, and antiviral efficacy of INCB009471, an orally available CCR5 antagonist. CCR5 antagonists are a new class of antiretroviral agents that block HIV entry into cells (see Drug Watch in the Winter 2007 issue of BETA).

Eligible participants must be 18-65 years of age and either antiretroviral-naive or off treatment for at least three months. They must have a CD4 count above 350 cells/mm3, a viral load greater than 10,000 copies/mL, and HIV that uses only the CCR5 coreceptor (viral tropism will be assessed at study entry). Exclusion criteria include certain illnesses (including hepatitis B or C and heart conditions), laboratory abnormalities, and use of certain medications (including herbal supplements). Women may not be pregnant or breastfeeding, and participants must agree to use effective barrier contraception. Subjects will be randomly assigned to receive 200 mg INCB009471 or placebo once daily with food for 14 days. Virological and safety assessments, including electrocardiograms, will be conducted regularly throughout the study.

This trial will enroll participants in Annandale, Boston, Los Angeles, Orlando, Vero Beach, and Washington, DC. For more information, call 302-498-6781 or email ksolomon@incyte.com. www.clinicaltrials.gov/ct/show/NCT00393120 (INCB 9471-201).


Protease Inhibitors and Glucose Metabolism

This randomized Phase IV study, sponsored by the Department of Veterans Affairs, will attempt to determine how PIs contribute to the development of diabetes in people with HIV -- in particular, whether PIs impair insulin secretion and increase the production of glucose by the liver. In order to separate out the effects of PIs from those of HIV itself, this study will enroll HIV negative volunteers. Participants will be randomly assigned to receive either a single dose of a PI or placebo. Insulin secretion will be assessed using the hyperglycemic clamp technique. Somatostatin, growth hormone, and glucagon will be infused before and during the clamp study. Liver glucose production will be measured in the fasting and hyperinsulinemic (excess insulin) states.

This study aims to enroll 80 healthy, HIV negative participants 18-72 years of age. Volunteers may not have medical conditions associated with insulin resistance, such as obesity or elevated blood fat levels, and may not be taking glucocorticoids, growth hormone, niacin, or antipsychotic medications. Women may not be pregnant. This study will take place at the San Francisco Veterans Affairs Medical Center (415-221-4810 ext. 2118 or ext. 3395). www.clinicaltrials.gov/ct/show/NCT00259727 (RCD-005-05S; H574-23263).


SUN Study: Natural History of HIV/AIDS

The SUN Study is a prospective observational cohort study sponsored by the Centers for Disease Control and Prevention (CDC) with the aim of better understanding the incidence, causes, and risk factors for metabolic and other complications related to effective HIV treatment and longer survival. The study will also evaluate a behavioral intervention designed to reduce HIV transmission through prevention counseling integrated into routine medical care.

For at least five years, participants will be followed with biannual physical examinations, noninvasive imaging (e.g., DEXA scans, carotid artery ultrasound), and regularly scheduled laboratory testing.

Eligible participants must be at least 18 years of age. Treatment-naive subjects (those with less than 30 days of consecutive exposure to antiretrovirals) must have a CD4 cell count between 100 and 500 cells/mm3. Treatment-experienced participants must have at least 100 cells/mm3 and have had at least two visits within the past year at the clinical facility where they are eligible for enrollment. Exclusion criteria include recent OIs and use of certain medications. Women may not be pregnant.

The study aims to enroll 1000 participants at HIV specialty care centers in Denver (303-393-8050 or 303-320-2830), Minneapolis (612-873-7516, 612-325-9520, or 952-993-3131), Providence (401-793-4025 or 401-793-5961), and St. Louis (314-289-6433 or 314-454-0058). www.clinicaltrials.gov/show/NCT00146419 (CDC-NCHSTP-3979; 200-2002-00610; 200-2002-00611; 200-2002-00612; 200-2002-00613).


TH9507 for Lipodystrophy

TH9507 is a growth hormone releasing factor (GRF) that has been shown to reduce visceral adipose tissue (VAT) and trunk fat in HIV positive individuals with excessive abdominal fat accumulation (see Drug Watch, in this issue).

In this Phase III trial, participants will be randomly assigned to receive 2 mg TH9507 or placebo for 26 weeks. Investigators will assess changes in VAT, blood lipids (cholesterol, triglycerides), and patient-reported perceptions of body image.

Eligible participants must be 18-65 years of age, have a CD4 cell count above 100 cells/mm3 and an HIV viral load below 10,000 copies/mL, and must have been on stable HAART for at least eight weeks. They must have evidence of abdominal fat accumulation, defined as a waist circumference greater than 95 cm for men or 94 cm for women, and a waist-to-hip ratio greater than 0.94 for men or 0.88 for women. Exclusion criteria include body mass index below 20 kg/m2, opportunistic infections or malignancies, untreated hypertension, certain laboratory abnormalities, and use of certain medications. Women may not be pregnant or breastfeeding and must have had a normal mammogram within six months.

The study is enrolling participants at some 30 U.S. sites (plus others in Canada and Europe), including Atlanta (404-876-2317 ext. 336), Austin (512-480-9660), Birmingham (205-934-2721), Boston (617-726-1696), Chapel Hill (919-843-2723), Chicago (773-296-2400 ext. 122), Cleveland (216-844-1389), Dallas (214-590-0414), Denver (303-436-8229), Ft. Lauderdale (954-524-2250), Houston (713-526-9821), Indianapolis (317-274-8456), Los Angeles (310-557-9680), Miami (305-944-2884), New York City (212-924-3934 ext. 105), Phoenix (602-307-5330), San Francisco (415-750-2005), Seattle (206-624-0688), and Tampa (813-875-4374). www.clinicaltrials.gov/show/NCT00435136 (TH9507-CTR-1011).


Omega-3 Fatty Acids for High Triglycerides

This study, sponsored by Reliant Pharmaceuticals and the National Center for Complementary and Alternative Medicine, will assess whether omega-3 (also known as N-3) fatty acids can help lower triglycerides in people with HIV. A recently published study has already shown that fish oil capsules, which contain omega-3 fatty acids, decreased triglyceride levels by about 25% in HIV positive patients (see News Briefs, in this issue).

In this Phase IV trial, participants with elevated triglycerides will be randomly assigned to receive either Omacor (an FDA-approved prescription omega-3 fatty acid supplement) or placebo. Investigators will assess changes in triglyceride levels from baseline, as well as cholesterol levels and markers of systemic inflammation, insulin resistance, and bone turnover.

Eligible participants must be at least 18 years of age, have an HIV viral load below 5000 copies/mL, and have been on stable antiretroviral therapy for more than three months. They must also have been on stable lipid-lowering therapy for two months prior to study entry, but still have had a fasting plasma triglyceride value between 250 and 1000 mg/dL on two occasions. Exclusion criteria include heart, liver, or kidney disease, uncontrolled hypertension, certain laboratory abnormalities, and use of certain medications. Women may not be pregnant or breastfeeding.

The study will enroll 48 subjects in Baltimore (410-955-2130) and Los Angeles (310-478-3711). www.clinicaltrials.gov/show/NCT00346697 (K23 AT002862-01).


Lifestyle Modification for Metabolic Syndrome

This randomized, case-control efficacy study, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is designed to assess the effects of an intensive 12-month lifestyle modification program on metabolic syndrome, with a primary endpoint of improved body composition (waist-to-hip ratio). Improvements in cholesterol and triglyceride levels, blood pressure, and other indicators of cardiovascular health are secondary endpoints of the trial.

Following an extensive screening process, participants randomized to the "Reach for Energy, Activity, and Cardiovascular Health" (REACH) cohort will complete seven-day food records, have periodic physical exams, and undergo sub-maximal stress tests and other physical therapy testing. This cohort will also attend individualized counseling sessions with a trained dietitian. Participants randomized to the observation-only cohort will attend one such counseling session and will receive monthly phone calls from the study investigators; this group will undergo the same exams and tests as those in the REACH cohort. Eligible participants must be 18 to 65 years of age, be HIV positive, and have three of the following five indicators of metabolic syndrome: waist circumference greater than 88 cm (35 inches) in women and 102 cm (40 inches) in men; triglycerides at least 150 mg/dL (or currently be taking anti-lipolytic drugs); high-density lipoprotein (HDL, or "good") cholesterol less than 50 mg/dL in women and 40 mg/dL in men; blood pressure at least 130/85 mm/Hg (or be on antihypertensive drug therapy); or fasting glucose at least 110 mg/dL. Exclusion criteria include starting a new antiretroviral drug within one month of joining the study; taking androgens, growth hormone, or megestrol acetate (Megace) within three months of study initiation; history of severe neuropathy, uncontrolled hypertension, arthritis, or other contraindications to exercise; current drug or alcohol abuse; and certain laboratory abnormalities. Women may not be breastfeeding, pregnant, or trying to conceive. The study is enrolling 80 participants in Boston (617-724-9109). www.clinicaltrials.gov/ct/show/NCT00111358 (49302-P1; R01DK-49302).


NGX-4010 for Neuropathy

This randomized, double-blind, placebo-controlled Phase III study will assess the safety and efficacy of NGX-4010, a dermal patch containing capsaicin (the chemical in chili peppers that gives them "heat"), for treating HIV-associated neuropathy. Trial participants will receive either active NGX-4010 patches or identical placebo patches, to be applied to the skin and worn for either 30 or 60 minutes. At study entry, subjects will be asked to rate their neuropathy-associated pain using numeric pain rating scale (NPRS) scores, and will record average 24-hour NPRS scores daily for 12 weeks. Follow-up visits will occur 4 and 8 weeks after study participation ends.

Eligible participants must have had documented neuropathy in both feet for at least two months prior to the study screening visit, as well as other neuropathy-related symptoms in the ankles or legs, must have intact, non-irritated skin over the areas to be treated, must not be hypersensitive to capsaicin, and may not be taking certain pain medications. Women may not be pregnant and must agree to use contraception for the duration of the study and for 30 days following exposure to the study drug.

The study is currently enrolling at sites across Australia, the United Kingdom, Canada, and the United States. U.S. sites are located in Arizona, California, Florida, Georgia, Hawaii, Illinois, Maryland, Michigan, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, and Washington. For more information, call 877-HIV-4010 or visit www.hivpatchstudy.com. www.clinicaltrials.gov/ct/show/NCT00321672 (C119).


Cervical Cancer

Numerous studies are underway to test various therapies for different stages of cervical cancer. Most trials involve combinations of chemotherapy drugs, and some also include radiation therapy or whole-body hyperthermia (temperature elevation). Eligibility and exclusion criteria vary, but some trials accept women with HIV. Some of the currently enrolling studies listed on the ClinicalTrials.gov Web site include:


Anal Cancer

This open-label Phase II study, sponsored by the AIDS-Associated Malignancies Clinical Trials Consortium and the National Cancer Institute, will evaluate a chemotherapy regimen for the treatment of stage I, II, or III anal carcinoma in people with HIV.

Participants will receive the monoclonal antibody cetuximab (Erbitux) intravenously for 1-2 hours on days 1, 8, 15, 22, 29, and 35, intravenous fluoroucacil continuously on days 1-4 and 29-32, and intravenous cisplatin for one hour on days 1 and 29. Beginning on day 1, patients will undergo radiation therapy five days per week for 5-7 weeks. Treatment will continue until there is evidence of disease progression or unacceptable toxicity. Investigators will assess treatment failure rates along with survival, treatment-related adverse events, changes in HIV viral load and CD4 cell count, development of OIs, and quality of life.

Eligible participants must be at least 18 years of age and have histologically confirmed stage I-IIIB invasive anal or perianal squamous cell carcinoma. Exclusion criteria include acute OIs, certain other types of cancer, peripheral neuropathy, certain laboratory abnormalities (including low blood cell counts), and prior chemotherapy or radiation therapy. Women may not be pregnant or breastfeeding.

The study will enroll 47 participants at six sites: Boston (617-667-9925), the Bronx (718-430-2302), La Jolla (858-822-5354), Los Angeles (310-206-8359), Philadelphia (215-829-6088), and St. Louis (314-362-8836). www.clinicaltrials.gov/show/NCT00324415 (CDR0000440065; AMC-045; AMC-026).


Treatment of Oral Warts

This Phase II trial, sponsored by Amarillo Biosciences, will evaluate low-dose interferon alpha lozenges as a treatment for oral warts caused by human papillomavirus (HPV) in HIV positive people on HAART.

All potential study participants will have their warts examined and measured at a screening visit, and a biopsy will be done to confirm HPV infection. Qualifying subjects will be randomly assigned to receive interferon or placebo lozenges for 24 weeks. Participants will have their warts examined every six weeks, and investigators will assess the change in the total area covered by warts at the end of therapy. Subjects will be reimbursed for travel expenses.

Eligible participants must be at least 18 years of age, taking a standard combination antiretroviral therapy regimen, and have at least two warts inside the mouth. Exclusion criteria include active OIs and use of oral or injected steroids and other medications for the treatment of oral warts.

The study will enroll 80 participants at six sites: Baltimore (410-706-7628), Boston (617-732-5500 ext. 32806), Chicago (312-996-4333), Dallas (214-828-8454), New York City (212-998-9626), and San Francisco (415-505-2408 or 415-476-3080). www.clinicaltrials.gov/show/NCT00454181 (03HUHI19).


Interactions Between Emergency Contraception and Efavirenz

This open-label Phase I pilot study, sponsored by Bristol-Myers Squibb, will assess whether blood levels of the hormonal emergency contraceptive levonorgestrel (Plan B) are altered by concurrent use of efavirenz. It will also evaluate changes in efavirenz levels, as well as levonorgestrel side effects and liver function tests with and without efavirenz.

Eligible women must be 18-45 years of age and HIV negative. Exclusion criteria include obesity, hepatitis B or C, and current use of hormonal contraceptives. Participants may not be pregnant or breastfeeding. The study will enroll 24 participants in Denver (720-848-0819) and Providence (401-793-4632). www.clinicaltrials.gov/show/NCT00482963 (06-1178).


Tenofovir to Prevent

Perinatal HIV Transmission This Phase I trial, sponsored by NIAID and the National Institute of Child Health & Human Development, will look at the safety, tolerability, and pharmacokinetics of single-dose tenofovir (Viread) given to women during labor and to their newborn infants. Tenofovir has been shown to effectively reduce the risk of vertical (mother-to-child) transmission in monkeys infected with a simian virus related to HIV. In this nonrandomized, open-label study, pregnant women will be assigned to one of two groups. Subjects in Cohort 1 will receive a single 600-mg dose of tenofovir at the start of labor or before planned cesarean section. They will also receive intravenous zidovudine (AZT), which is standard therapy for preventing vertical transmission in developed countries, and/or other antiretroviral medications prescribed by their physician. Infants born to women in Cohort 1 will receive the standard six-week postpartum oral AZT prophylaxis regimen. After eight-week data from infants in Cohort 1 have been analyzed, a second cohort of pregnant women will receive a single dose of tenofovir (with the dose to be determine based on pharmacokinetic data from Cohort 1) plus standard AZT prophylaxis and/or other antiretroviral drugs. Infants born to women in Cohort 2 will receive a single dose of tenofovir within six hours after birth, along with the standard six-week AZT regimen. Blood samples will be collected from mothers and infants to assess tenofovir pharmacokinetics and resistance. The women will be followed for 12 weeks postpartum; if viral resistance to tenofovir emerges during this period, they will be followed for two years. Infants will be followed until age 2.

Eligible women must be at least 18 years of age and in their third trimester of pregnancy (at least 34 weeks gestation). There are no viral load or CD4 cell count restrictions. Exclusion criteria include previous treatment with tenofovir, various medical conditions (including active OIs), abnormal laboratory results, and current or prior use of certain medications. Ultrasound screening must show a normal pregnancy and mothers must agree not to breastfeed.

This study aims to enroll 20 women at 30 sites, including Boston (617-355-8198), the Bronx (718-960-1020), Chicago (773-257-5717), Denver (303-861-6751), Detroit (313-745-7857), Durham (919-416-3447), Houston (832-824-1339), Los Angeles (323-226-2226), Memphis (323-669-2390), Miami (305-243-4447), Newark (973-972-3118), New York City (212-263-5680), Philadelphia (215-427-5284), San Diego (619-543-8080), San Francisco (415-476-6480), San Juan (787-765-4186), Seattle (206-987-5020), and Washington, DC (202-877-5811). www.clinicaltrials.gov/ct/show/NCT00076791 (PACTG 394).


Effect of Stress Reduction on Immune Function and Side Effects

The Staying Well study, sponsored by the National Center for Complementary and Alternative Medicine, is a controlled trial of mindfulness-based stress reduction (MBSR) for people with HIV. The study aims to determine whether stress reduction through meditation is associated with reduced HIV disease progression (as determined by CD4 cell count and viral load measurements), less depression, and improved quality of life; it will also assess the mechanisms by which stress and mood may influence immune function.

In this Phase II study, subjects will be randomly assigned to participate in either MBSR or general education on health and well-being for HIV positive individuals. Both groups will attend eight weekly sessions at the Osher Center for Integrative Medicine at the University of California at San Francisco (UCSF). Participants will have blood drawn and will complete psychological questionnaires at study entry and at months 3, 6, and 12; they will receive compensation for each completed assessment. Those initially assigned to the education group may participate in the MBSR program for free after 12 months.

Eligible subjects must be at least 18 years of age and able to speak English. They must not have taken antiretroviral therapy for the past 120 days, and must have an HIV viral load greater than 100 copies/mL and a CD4 cell count above 250 cells/mm3 at study entry. They should not plan to start HAART during the 12 months following enrollment, but may do so if medically necessary and remain in the study. Exclusion criteria include previous MBSR training or current practice and recent use of certain medications.

The study aims to enroll 330 participants in San Francisco (415-353-9745). www.clinicaltrials.gov/show/NCT00271856 (P01 AT002024).

A related randomized Phase I/II study, also to be conducted at UCSF, will explore the effects of a mindfulness-based stress reduction program on medication-related side effects in HIV positive individuals taking antiretroviral therapy. In this study, 100 treated patients will participate in the MBSR program for eight weeks. The control group will consist of 50 subjects on the waiting list for the program. The primary outcome measure will be the number and severity of side effects reported by patients; health-related quality of life and adherence to antiretroviral therapy will also be assessed.

Eligible subjects must be at least 18 years of age and able to speak English. They must have been on standard combination antiretroviral therapy for at least the past 30 days and must have experienced significant bothersome side effects (to be rated using a side effect and symptom distress scale) for the previous 30 days. Exclusion criteria include current enrollment in an MBSR program or related study, severe cognitive impairment, active psychosis, and active substance abuse that would interfere with MBSR participation.

The study aims to enroll 100 participants in San Francisco (415-597-9374). www.clinicaltrials.gov/show/NCT00312936 (R21 AT003102-01).


Project T: Tenofovir to Prevent HIV Infection

The CDC, in conjunction with the San Francisco Department of Public Health (SFDPH), the AIDS Research Consortium of Atlanta, and the Fenway Community Health Center in Boston, is conducting a double-blind Phase II trial to assess whether tenofovir can be used as preexposure prophylaxis (PrEP) to prevent infection, as suggested by animal studies.

Participants will be randomly assigned to receive either daily oral tenofovir or a placebo, and will be followed every three months for two years. This phase of the study will focus on the safety of the drug and whether use of a potentially protective agent leads to an increase in high-risk sexual behavior. Because it is not yet known whether tenofovir can prevent HIV infection -- and because some subjects will receive placebo -- participants should continue to practice safer sex, and they will receive risk-reduction counseling and free condoms. If any participants become infected, SFDPH will facilitate referrals for HIV care and treatment.

Eligible participants must be sexually active HIV negative men aged 18-60 years who have sex with men or transgender (male-to-female) women. Exclusion criteria include certain medical conditions (including impaired kidney or liver function and bone disease) and use of certain drugs (including nephrotoxic medications). The study is enrolling participants in San Francisco (415-554-8888; www.helpfighthiv.org/projt.htm), Atlanta (404-876-2317; www.aidsresearchAtlanta.org/TheT), and Boston (617-927-6450). www.clinicaltrials.gov/show/NCT00131677 (CDC-NCHSTP-4323).


Elite Controller Study

The Elite Controller Study is a collaborative effort to understand factors associated with long-term non-progression of HIV disease. The study defines "controllers" as individuals able to maintain low HIV viral loads (below 2000 copies/mL) without treatment, and "elite controllers" as those able to maintain undetectable HIV RNA levels (below 50 copies/mL). The investigators will assess multiple viral and host characteristics, including genetic variations such as the CCR5∆32 mutation, which is associated with resistance to HIV infection and slow disease progression.

Eligible participants will be HIV positive adults 18-75 years of age. They must not be on antiretroviral therapy and must have viral loads below 2000 copies/mL and asymptomatic infection. Candidates will first undergo a one-time blood draw by their local provider. The sample will be sent to the study coordinators and analyzed to determine eligibility. The coordinators will then arrange for further participation.

This collaborative study is coordinated by Bruce Walker, MD, of Partners AIDS Research Center at Massachusetts General Hospital in Boston, and includes participating researchers and community advocacy groups in Chicago, Durham, Los Angeles, Nashville, New York City, San Diego, San Francisco, Seattle, and in Canada, Europe, and Australia. The researchers hope to identify 700-800 HIV controllers worldwide; individuals who believe they may qualify need not live in one of these cities. For more information or to discuss eligibility, contact Rachel Rosenberg (617-726-5536; rrosenberg2@partners.org) or Florencia Pereyra (fpereyra@partners.org). www.mgh.harvard.edu/aids/hiv_elite_controllers.asp.


Bupropion to Reduce Methamphetamine Use

The BUMP study, conducted by SFDPH, is designed to evaluate whether an antidepressant medication can help gay and bisexual men stop using or reduce their use of methamphetamine. Researchers also will assess whether this helps reduce high-risk sexual behavior, such as anal sex without a condom.

Subjects will be randomly assigned to receive either the antidepressant bupropion (Wellbutrin, Zyban) -- which is also prescribed to aid smoking cessation -- or a placebo for 12 weeks. If this approach proves feasible, the investigators plan to conduct a larger trial. Study visits will take place weekly and will include a urine test; participants will receive $10-$35 per visit.

Eligible participants must be men at least 18 years of age, either HIV positive or HIV negative, who have engaged in anal sex with men while using methamphetamine in the past three months. Exclusion criteria include acute illnesses, history of seizures, liver or kidney dysfunction, and use of certain medications. The study is enrolling participants in San Francisco (415-554-9013 or 415-703-7273; sf.bump@sfdph.org). www.clinicaltrials.gov/show/NCT00318409 or www.sfbump.com (R21DA021090-1).





  
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This article was provided by San Francisco AIDS Foundation. It is a part of the publication Bulletin of Experimental Treatments for AIDS. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.
 

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