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Open Clinical Trials for HIV/AIDS Treatments

Summer 2004


Below is a selection of currently enrolling U.S. clinical trials gathered from various sources. TrialScope is a database of organizations that conduct HIV/AIDS-related research. It provides contact information for each research site, links to organizational Web sites, the types of research conducted by each site, and any affiliations with major multicenter research groups.

The federal government's AIDSinfo site includes a section on clinical trials. It features an introduction to HIV/AIDS research and study listings from the National Institutes of Health's ClinicalTrials.gov database. AIDSinfo also has a toll-free phone service at 800-874-2572. Specialists are on hand Monday through Friday from 12:00 pm to 4:00 pm ET (9:00 am to 1:00 pm PT) to help locate trials and answer questions. Like ClinicalTrials.gov, the CenterWatch Web site also includes trial listings for all diseases including HIV/AIDS and related conditions.

Community Programs for Clinical Research on AIDS (CPCRA) is a nationwide network that conducts community-based clinical trials. The AIDS Community Research Initiative of America (ACRIA) provides a listing of trials mostly in the mid-Atlantic region (New York, New Jersey, Connecticut, and Pennsylvania).

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The Body Web site has created a new database of prospective clinical trial volunteers. The service collects information about participants' city, age, viral load, current and past anti-HIV therapy, and health status. Researchers can request information about prospective subjects, who will be contacted if they meet a trial's enrollment criteria. The application form is available at www.thebody.com/redirect/trialapply.html.

Call the telephone numbers listed for each study or see the indicated Web sites for more information about specific trials. Protocol (study) numbers, if available, are provided in parentheses at the end of the trial descriptions.


SMART: Drug Conservation vs. Viral Suppression

The SMART study, conducted by the Community Programs for Clinical Research on AIDS (CPCRA), is a large, simple trial comparing two HIV treatment strategies. The study will attempt to determine whether participants at low risk of disease progression can safely reduce their use of antiretroviral therapy, thus minimizing side effects, slowing the development of drug resistance, and conserving future treatment options. Participants randomly assigned to the drug conservation arm will stop (or not start) anti-HIV therapy until their CD4 cell counts fall below 250 cells/mm3, at which point they will begin therapy and continue until their CD4 cell counts rise above 350 cells/mm3. Those assigned to the viral suppression arm will continue (or start) treatment in an attempt to keep viral load as low as possible, regardless of CD4 cell count. Some 6,000 participants will be followed for an estimated 6-9 years, until about 900 primary events (disease progression or death) occur. Selected participants will be followed with more intensive data collection for secondary outcomes related to cost, health-care utilization, metabolic complications, and quality of life.

Participants must be at least 13 years of age and have a CD4 cell count above 350 cells/mm3 within 45 days of study entry. Subjects may be using any available antiretroviral or immune-modulating drugs at study entry. They must be in reasonably good health and available to continue the study for at least six months. Women may not be pregnant or breast-feeding, and both female and male participants must be willing to use effective contraception.

There are more than 60 study sites, including Atlanta (404-876-2317 ext. 324), Boston (617-778-5454), Brooklyn (718-270-4487), Chicago (773-244-5802), Denver (303-436-7195), Detroit (313-745-4431), Houston (713-500-6751), Los Angeles (323-860-7330), Miami (305-324-4455 ext. 4942), Newark (973-483-3444), New Orleans (504-584-1971), New York City (212-939-2957), Philadelphia (215-707-8846 ext. 220), Portland (503-229-8428), Richmond (804-828-6471), San Francisco (415-476-9554 ext. 22), and Washington, DC (202-745-8301); www.clinicaltrials.gov/ct/show/NCT00027352 or www.smart-trial.org. (CPCRA 065)


First Therapy for Treatment-Naive Individuals

This study will evaluate the safety and effectiveness of combinations of approved antiretroviral drugs for HIV-positive individuals who have not received prior therapy. All subjects will be monitored at 12 scheduled clinic visits over a 48-week period and will have a follow-up visit or telephone call four weeks after the last study visit.

Eligible participants must be at least 18 years of age and may not have received antiretroviral therapy for more than 14 days in the past. Women may not be pregnant or breast-feeding and must agree to use birth control.

The study will be conducted at more than 50 sites, including Atlanta (770-431-4247), Charlotte (704-331-9054), Chicago (773-702-1209), Cleveland (216-444-0214), Dallas (214-941-4000), Denver (303-764-4776), Los Angeles (310-550-1010), Miami (305-243-5621), Newark (973-877-2595), New Orleans (504-903-7890), Philadelphia (215-707-8846), San Francisco (415-221-4810, ext. 763), and St. Louis (314-454-1931); www.clinicaltrials.gov/ct/show/NCT00082394. (ESS100327)


Once-Daily vs. Twice-Daily HAART and DOT

This open-label Phase II study will compare once-daily vs. twice-daily administration of antiretroviral drugs, and will also look at self-administered vs. directly observed therapy (DOT). The trial is for people who are taking anti-HIV therapy for the first time. Participants will be randomly assigned to one of three study arms. All will receive the same daily dosages of lopinavir (Kaletra), emtricitabine (FTC, Emtriva), and extended-release d4T (stavudine, Zerit). Participants in Arm A will self-administer lopinavir twice daily, and emtricitabine and d4T once daily for 48 weeks. Arm B participants will self-administer all three drugs once daily for 48 weeks. Those in Arm C will take all three drugs once daily in the presence of a clinician for 24 weeks, then by self-administration for 24 additional weeks. The study will measure safety, efficacy, tolerability, and quality of life.

Participants must be at least 13 years of age and have a viral load of at least 2,000 copies/mL within 90 days of study entry. They must not have taken any antiretroviral drugs for more than seven days. Participants are ineligible if they have recently had certain illnesses or taken certain medications, including those that may cause pancreatitis (inflammation of the pancreas) or peripheral neuropathy. Women may not be pregnant or breast-feeding, and both female and male participants must use effective contraception.

There are more than 20 sites, including Baltimore (410-614-4487), Cleveland (216-778-5489), Denver (303-372-5535), Indianapolis (317-274-8456), Miami (305-243-3838), New York City (212-263-6565), Philadelphia (215-349-8092), Providence (401-793-4396), Rochester (585-275-2740), Sacramento (916-734-8637), San Juan (787-767-9192), and Seattle (206-731-8877); www.clinicaltrials.gov/ct/show/NCT00036452. (ACTG A5073)


When to Start HAART in People With OIs

This study will attempt to determine when is the best time to start antiretroviral therapy in individuals presenting with opportunistic illnesses (OIs). Immediately starting HAART may be disadvantageous and anti-HIV medications can interact with drugs used to treat OIs. This trial will compare the benefits and drawbacks of starting antiretroviral therapy immediately vs. waiting until after OI treatment is underway or completed. Participants will be randomly assigned either to begin antiretroviral therapy within two months of starting OI treatment (Arm A), or to defer anti-HIV treatment until at least four weeks -- but no more than 32 weeks -- after beginning OI therapy. All subjects will receive lopinavir plus d4T, and may also receive a third and fourth anti-HIV drug at the discretion of study clinicians. The study will last 48 weeks and participants will have ten study visits, which will include blood tests, physical examinations, and questionnaires.

Eligible participants must be at least 13 years of age. They must have a confirmed or suspected acute OI, including Pneumocystis carinii pneumonia (PCP), bacterial pneumonia, cryptococcal meningitis, disseminated histoplasmosis, disseminated Mycobacterium avium complex (MAC), cytomegalovirus (CMV) retinitis or encephalitis, or toxoplasmic encephalitis. Participants may not have been on antiretroviral therapy within six months of study entry or for a total of six months at any time prior to joining the study, and may not have been treated for their current OI for more than 14 days prior to study entry. Certain medical conditions and recent use of certain medications are excluded. Women may not be pregnant or breast-feeding, and all subjects must be willing to use effective contraception.

The study will enroll 282 participants at more than 20 sites, including Boston (617-732-5635), Chapel Hill (919-843-8761), Denver (303-372-5535), Galveston (409-747-0241), Indianapolis (317-274-8456), Miami (305-243-3838), New York City (212-305-2665), Rochester (585-275-2740), San Francisco (415-514-0550 ext. 354), Stanford (650-723-2804), and St. Louis (314-454-0058); www.clinicaltrials.gov/ct/show/NCT00055120. (ACTG A5164)


Tipranavir Open-Label Study

Boehringer Ingelheim has expanded its open-label safety study of tipranavir, an investigational nonpeptidic protease inhibitor (PI) currently in Phase III development. The expanded study, part of the company's RESIST program, has broader enrollment criteria and twice the number of study sites, and will allow 50 more individuals per month to participate. The nonrandomized open-label study is for individuals who are failing or unable to tolerate their current therapy and need a new PI to construct a viable regimen. All subjects will receive 500 mg tipranavir plus 200 mg ritonavir (Norvir) twice daily; there is no placebo arm.

Prospective subjects must be at least 13 years of age and must be failing to achieve virological suppression on their current regimen, with a CD4 cell count of 100 cells/mm3 or less and a viral load of 10,000 copies/mL or more. They must not have certain medical conditions (including liver impairment) and may not be taking certain drugs. Women may not be pregnant or breast-feeding and must agree to use a barrier method of contraception. Participants may not join the open-label study if they are eligible for another tipranavir trial in their area.

The open-label study is being conducted at more than 60 sites, including Atlanta, Baltimore, Boston, Chicago, Cincinnati, Detroit, Houston, Las Vegas, Los Angeles, Madison, Nashville, Newark, New Orleans, New York City, Philadelphia, San Francisco, Santa Fe, Seattle, St. Louis, Tampa, and Washington, DC. For more details and local contact information, call the Boehringer Ingelheim study hotline at 800-632-2464; www.clinicaltrials.gov/ct/show/NCT00062660. (BI 1182.58)


New Entry Inhibitor: SCH-D

This Phase II study will examine the safety and effectiveness of a new oral entry inhibitor, Schering-Plough's SCH-D (also known as SCH 417690), in treatment-experienced individuals whose current antiretroviral regimens are failing. SCH-D targets the CCR5 receptor on human cells and prevents HIV from entering (see "Drug Watch" in this issue). Participants will be randomly assigned to receive one of three different doses of the drug (5 mg, 10 mg, or 15 mg) or placebo daily for 48 weeks. Subjects will also remain on their current anti-HIV drugs, which are not provided by the study; after two weeks, participants will begin an optimized antiretroviral regimen based on the results of genotypic/phenotypic resistance testing. Study visits with blood draws will take place on day 4 and at weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Subjects will also undergo electrocardiograms (EKGs) at weeks 2, 8, 24, and 48, and will be tested for peripheral neuropathy.

Prospective subjects must be at least 18 years of age and must be experiencing virological failure on their current antiretroviral regimen (HIV viral load of at least 5,000 copies/mL within six weeks of study entry). The current regimen must include ritonavir, and must have been stable for at least eight weeks prior to study entry. Participants will be tested to ensure that they have a type of HIV that uses CCR5 (not CXCR4) coreceptors. Subjects may not have taken efavirenz (Sustiva) or nevirapine (Viramune) within eight weeks of study entry, or certain other medications (including immunosuppressants, immune modulators, or cancer chemotherapy) within the past 30 days. They may not have hepatitis B or C coinfection or a history of seizures. Women may not be pregnant or breast-feeding, and all participants must be willing to use effective contraception.

The study will enroll participants at 15 U.S. study sites, including Boston (617-414-7082), Honolulu (808-737-2751), New York City (212-476-4393), and Stanford (650-723-2804); www.clinicaltrials.gov/ct/show/NCT00082498. (ACTG A5211)


New NRTI: D-D4FC

This double-blind Phase II trial will explore the safety, tolerability, and efficacy of D-D4FC (Reverset; see "Drug Watch" in this issue), a new nucleoside reverse transcriptase inhibitor (NRTI). Treatment-experienced subjects will receive 50, 100, or 200 mg doses of D-D4FC, or placebo, once daily in combination with other antiretroviral drugs. At week 2, participants' regimens will be optimized based on the results of genotypic resistance testing; further reoptimization may be done at week 16. Also at week 16, those initially randomized to receive placebo will begin receiving 100 or 200 mg of D-D4FC. After 24 weeks, selected participants will have the option to enroll in an extension study.

Eligible subjects must be adults experiencing virological failure on their current regimens, with a viral load of at least 2,000 copies/mL and a CD4 cell count greater than 50 cells/mm3.

Study sites include Baltimore (410-614-1338), Boston (617-778-5454 ext. 223), Chicago (312-695-5045), Ft. Lauderdale (954-524-2250), Galveston (409-747-0203), Houston (713-526-9821), Los Angeles (323-343-8283), Miami (305-243-3838), New York City (212-420-4519), San Francisco (415-476-9296 ext. 303), Tampa (813-307-8015 ext. 6443), and Washington, DC (202-741-2443). (INCB 8721 RVT-203)


Ribozyme Gene Therapy

This study will explore whether gene therapy can alter immune system white blood cells so they can better fight HIV. In this study, a gene encoding a ribozyme (a type of enzyme) will be inserted into blood-forming stem cells, and the cells will be returned to the body. As the stem cells give rise to new white blood cells such as macrophages and T cells, the researchers hope that the ribozyme inside the cells will destroy HIV. Participants will be randomly assigned to receive the ribozyme gene or a "dummy" gene. The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have reviewed the study and believe the procedure is safe.

Prospective participants must be 18-45 years of age and on their first or second anti-HIV regimen. They must have well-controlled HIV, with a viral load of 400 copies/mL or less and a CD4 cell count of at least 300 cells/mm3. Pregnant women and individuals with a history of AIDS-defining illness are not eligible.

The study will enroll 70 participants in Los Angeles (310-794-9668), Stanford (650-723-6231), and a center in Sydney, Australia.


Blood Sugar Abnormalities in Pregnant Women

This study will look at the incidence of blood sugar abnormalities in HIV-positive pregnant women taking antiretroviral therapy. The trial will enroll 160 women, who will be followed every eight weeks from study entry through delivery, with a final visit 12 weeks after delivery. Glucose tolerance tests and other metabolic measurements will be performed. Newborn infants will also be evaluated at birth and at 12 weeks of age. This is an observational study of women already using anti-HIV therapy; drugs will not be provided.

Eligible women must be at least 13 years of age and be 20-24 weeks pregnant at study entry. They must have been on stable antiretroviral therapy including a PI for the eight weeks immediately prior to joining the study, and must plan to continue that regimen throughout the trial. Participants are not eligible if they currently have diabetes, although they may have a history of blood sugar problems during past pregnancies. Participants may not have a recent serious medical condition or have recently used certain medications, including steroids or drugs to control blood sugar or blood lipids (fats).

The study will be conducted at nearly 40 sites including Baltimore (410-706-8933), Birmingham (205-558-2328), Boston (617-732-5635), Chicago (773-257-5717), Cleveland (216-844-8051), Detroit (313-745-7857), Durham (919-684-8216), Honolulu (808-737-2751), Indianapolis (317-274-8456), Los Angeles (323-226-2342), Miami (305-243-2154), Minneapolis (612-625-1462), Nashville (615-467-0154 ext. 105), Newark (973-972-3118), New York (212-263-6565), Pittsburgh (412-647-0771), San Juan (787-765-4186), Seattle (206-528-5020), St. Louis (314-454-0058), and Washington, DC (202-865-4578); www.clinicaltrials.gov/ct/show/NCT00017797. (ACTG A5084)


Metabolic Abnormalities in Young Women

This study will look at metabolic complications in young women with HIV, including abnormal blood glucose and lipid levels, body fat changes, and bone density alterations. The study will compare metabolic parameters in HIV-negative women, HIV-positive women who have never used HAART, and HIV-positive women taking regimens that include non-nucleoside reverse transcriptase inhibitors (NNRTIs) but no PIs, PIs but no NNRTIs, or neither PIs nor NNRTIs. In this cross-sectional observational study, participants will be seen just one time; the visit will include a questionnaire, a DEXA scan to assess body composition, and blood tests to measure glucose, lipid, and lactic acid levels.

Eligible women must be 12-24 years of age. Both HIV-negative and HIV-positive participants are needed, and those with HIV may be taking any type of antiretroviral therapy, or not be on treatment at all. Subjects are not eligible if they have type 1 diabetes or type 2 diabetes that must be controlled with daily medication. Participants may not be pregnant currently or within the past year.

Study sites include Chicago (312-572-4571), Los Angeles (323-660-2450 ext. 3914), Miami (305-243-3442), New Orleans (504-588-5348), New York (212-423-2867), Philadelphia (215-590-4954), San Diego (619-543-8080), Tampa (813-259-8799), and Washington, DC (202-884-3714); www.clinicaltrials.gov/ct/show/NCT00067587. (ATN 021)


Metabolic Abnormalities in Children and Youth

This study will examine the prevalence of metabolic and physical abnormalities in HIV-positive children, adolescents, and young adults who were infected via mother-to-child transmission. Metabolic parameters, body composition, bone density, and other factors will be assessed to see whether there is an association with antiretroviral therapy. The trial will include three groups: HIV-positive children and youth receiving antiretroviral regimens containing PIs, HIV-positive subjects taking PI-sparing regimens, and an HIV-negative control group. Participants will receive blood tests and whole-body DEXA scans to assess bone density.

Eligible participants must be 7-25 years of age. Both HIV-positive and -negative subjects are needed. HIV-positive subjects in the PI group must have been on a stable PI-containing regimen for at least 12 months, while the PI-sparing group must not have used a PI within 12 months of study entry and must not have been exposed to PIs for more than two weeks in the past. Participants may not have type 2 diabetes that must be controlled with drugs and may not be taking certain medications including growth hormone, glucocorticoids, or anabolic steroids. Female subjects may not be pregnant currently or within the past year.

The study is expected to enroll 450 participants at about 20 sites, including Birmingham (205-558-2328), Boston (617-355-8198), Denver (303-861-6751), Detroit (313-745-7857), Los Angeles (323-226-2226), Memphis (901-495-3490), Newark (973-972-3118), New York City (212-939-4045), Oakland (510-428-3885 ext. 2827), Philadelphia (215-427-5284), San Diego (619-543-8080), and San Francisco (415-476-6480); www.clinicaltrials.gov/show/NCT00069004. (PACTG P1045)


Metformin and Rosiglitazone for Lipid and Insulin Abnormalities

This double-blind trial will evaluate the effect of metformin (Glucophage) and rosiglitazone (Avandia), taken alone or in combination, on elevated insulin levels and body fat accumulation in the abdomen and other areas. Metformin and rosiglitazone are currently FDA-approved for these indications in HIV-negative people. Participants will be randomly assigned to receive either metformin plus rosiglitazone placebo, rosiglitazone plus metformin placebo, metformin plus rosiglitazone, or placebos of both drugs. After 16 weeks participants who remain in the study will be switched to an open-label phase and all will receive metformin plus rosiglitazone for an additional 16 weeks. Clinic visits will take place at weeks 2, 4, 8, 12, 16, 18, 20, 24, 28, and 32, and will include blood draws to assess insulin and glucose levels (this must be done after fasting overnight). In addition, visceral (internal) fat, subcutaneous fat, and thigh size will be measured.

Participants must be 18-65 years of age and have a viral load below 10,000 copies/mL within 30 days of study entry. They must have specific blood insulin levels and meet physical restrictions based on height, weight, and amount and location of body fat. Subjects must be on a stable anti-HIV regimen for at least 60 days prior to study entry. Participants may not have previously taken drugs to control blood sugar. They may not be taking ritonavir with either simvastatin (Zocor) or lovastatin (Mevacor). Subjects are ineligible if they have certain medical conditions or have recently taken certain medications. Women may not be pregnant or breast-feeding, and all participants must be willing to use effective contraception.

There are more than 30 study sites, including Baltimore (410-614-4487), Birmingham (205-975-7925), Boston (617-726-3819), Chapel Hill (919-843-8761), Chicago (312-695-5012), Cincinnati (513-584-8373), Denver (303-372-5535), Honolulu (808-737-2751), Indianapolis (317-274-8456), Los Angeles (310-206-8029), Nashville (615-467-0154 ext. 109), New York (212-420-4432), Omaha (402-559-8163), Pittsburgh (412-647-0771), San Francisco (415-514-0550 ext. 362), Seattle (206-731-8877), St. Louis (314-454-0058), and Washington, DC (202-687-5378); www.clinicaltrials.gov/ct/show/NCT00015691. (ACTG A5082)


Oyster Mushrooms for Hyperlipidemia

This open-label "proof of concept" study will evaluate the short-term safety and potential efficacy of oyster mushrooms for the treatment of elevated blood fats (hyperlipidemia) in HIV-positive subjects taking lopinavir. Participants will take freeze-dried oyster mushroom powder, which can be added to soup or other foods, once daily for eight weeks. Subjects will have two overnight stays at San Francisco General Hospital, during which blood will be drawn several times, plus three outpatient visits; they will be reimbursed $50 for each overnight stay and $25 for each outpatient visit.

Eligible participants must be at least 18 years of age and must have been taking lopinavir for at least 12 weeks. They must have an elevated non-HDL cholesterol level (at least 190 mg/dL) and normal liver function tests within 30 days of study entry. Prospective subjects may not currently be using lipid-lowering drugs, and may not have diabetes, rhabdomyolysis (a type of muscle damage), or certain other medical conditions. Women may not be pregnant or breast-feeding.

The study will enroll 20 participants in San Francisco (415-476-9554 ext. 315); www.clinicaltrials.gov/ct/show/NCT00069524. (AT001782-01)


Testosterone for Men With Lipodystrophy

This double-blind study will examine whether testosterone supplements can help reduce abdominal fat accumulation in HIV-positive men with low testosterone levels (hypogonadism) taking antiretroviral therapy. Testosterone has been shown to decrease abdominal fat in HIV-negative men (see "HIV and Hormones" in this issue). Participants will receive either testosterone gel or a placebo gel applied to the skin once daily for 24 weeks. Those who receive testosterone during the first 24 weeks will be eligible to continue therapy for 24 more weeks. Those receiving placebo gel will be followed for an additional 24 weeks. All subjects will remain on their current antiretroviral regimens. Tests for visceral fat changes will be performed throughout the study period.

HIV-positive men 18-70 years of age are eligible for this study. Participants must have been on anti-HIV therapy for at least 12 weeks before study entry and plan to continue for at least 24 additional weeks. They must have an abdominal girth of at least 100 cm (39.4 inches), with an increase since starting HAART. Viral load must be less than 10,000 copies/mL and total serum testosterone must be 125-400 ng/dL. Subjects may not have diabetes, cancer, active OIs, or certain other medical conditions, and must not be taking certain drugs including testosterone derivatives, anabolic steroids, DHEA, glucocorticoids, antidiabetes medications, dronabinol (Marinol), megestrol acetate (Megace), or growth hormone.

A total of 86 participants will be enrolled at more than 20 study sites, including Chicago (312-695-501), Denver (303-372-5535), Honolulu (808-737-2751), Indianapolis (317-274-8456), Minneapolis (612-625-1462), New York City (212-263-6565), Philadelphia (215-349-8092), San Diego (619-543-8080), San Francisco (415-514-0550 ext. 362), San Juan (787-767-9192), and St. Louis (314-454-0058); www.clinicaltrials.gov/show/NCT00009555. (ACTG A5079)


Testosterone for Premenopausal Women With Wasting

This study will examine whether physiological testosterone supplements that bring testosterone levels up into the normal natural range can increase lean body weight, improve muscle function, and improve quality of life in women with HIV. Participants will be randomly assigned to use two testosterone skin patches, one testosterone and one placebo patch, or two placebo patches applied twice weekly (every 3-4 days) for 12 weeks.

Prospective participants must be premenopausal women aged 18-50 years. They must have experienced weight loss of 5-15% and must have a total testosterone level less than 30 ng/dL. Subjects may be taking any stable antiretroviral regimen, and must not have used any anabolic or androgenic steroids or hormonal contraceptives for three months. Hormone replacement therapy (HRT) is not allowed. Exclusion criteria also include significant liver or cardiovascular disease, uncontrolled high blood pressure, active OIs, diabetes, use of street drugs within the past six months, and pregnancy and/or breast-feeding.

The study will enroll 56 women in Los Angeles (213-563-9353) and St. Louis (314-222-2444); www.clinicaltrials.gov/ct/show/NCT00004400. (199/13251; CDUMS-FDR001397)


Growth Hormone to Reduce Abdominal Fat

This Phase III study, sponsored by Serono, will assess the use of recombinant human growth hormone (Serostim) as a treatment for visceral fat accumulation and abnormal body fat distribution. Participants will be randomly assigned to receive either 4 mg of Serostim or placebo daily for 12 weeks.

Prospective subjects must be 18-60 years of age; both men and women are eligible. They must have evidence of excess abdominal fat (waist circumference greater than 88.2 cm, or 34.7 inches, and waist-to-hip ratio of at least 0.95 for men; waist circumference greater than 75.3 cm, or 29.6 inches, and waist-to-hip ratio of at least 0.9 for women). Subjects may be taking any stable regimen of approved antiretroviral drugs and must agree to remain on the same regimen for the duration of the study unless a change is medically necessary. Participants must have liver enzyme, triglyceride, and glucose levels within the normal range. They may not have active OIs, untreated high blood pressure, or a history of diabetes, cancer, pancreatitis, coronary artery disease, or certain other medical conditions. They may not be taking certain medications including antidiabetes drugs, interferon, glucocorticoids, or androgenic agents such as testosterone. Women may not be pregnant or breast-feeding and must agree to use effective contraception.

Study sites include Atlanta (404-876-2317 ext. 336), Austin (512-480-9660), Birmingham (205-975-9127), Boston (617-636-0492), Chicago (312-942-5000 ext. 29156), Ft. Lauderdale (954-524-2250), New York City (212-523-3671), Palm Springs (760-325-4590), and West Hollywood (310-358-2429); www.clinicaltrials.gov/ct/show/NCT00082628. (24380)


Growth Hormone and Immune Function

This study will examine how growth hormone (GH) influences immune function in people with HIV. Research has shown that GH promotes the growth of the thymus gland, an important site of T cell production in children and possibly adults. The study will assess whether growth hormone induces thymus growth and a consequent increase in T cell proliferation. Participants will be followed for two years. One arm will receive GH by subcutaneous injection during the first 12 months (3 mg daily for the first six months, then reduced to 1.5 mg daily). The other arm will be observed for the first 12 months and then begin receiving GH during the second year. Study visits, which will take place about every 1-3 months, will include physical exams, blood tests, and different types of body scans (CT, PET, DEXA).

Eligible participants must be at least 18 years of age and must be taking at least two antiretroviral drugs. They must have a CD4 cell count of 400 cells/mm3 or less and a viral load less than 1,000 copies/mL for one year prior to study entry. They may not have diabetes, cancer, some forms of heart disease, or carpal tunnel syndrome. Women may not be pregnant or breast-feeding.

The study will enroll 24 participants in San Francisco (415-695-3820); www.clinicaltrials.gov/ct/show/NCT00071240. (R01; AI43864)


Endothelial Dysfunction

This study will look at whether endothelial (blood vessel lining) changes are a risk factor for cardiovascular disease in people taking HAART. It will also evaluate the effect of three different medications on blood lipid levels and insulin resistance. Participants will receive pravastatin (Pravachol), gemfibrozil (Lopid), rosiglitazone (Avandia), or a placebo for six weeks; those who started on an active drug will later be switched to a placebo, and vice versa. Blood assays and endothelial function tests will be performed throughout the study.

Prospective participants must be at least 18 years of age and have been on stable antiretroviral therapy for at least two months preceding study entry. They must not smoke more than a pack per day of cigarettes and must abstain from caffeine during the study. Subjects may not have a history of coronary artery disease, heart failure, myocardial infarction (heart attack), high blood pressure, liver or kidney disease, or diabetes, and may not be taking certain medications. Women must not be pregnant or breast-feeding and all participants must be willing to use a barrier method of contraception.

The study will enroll 75 participants in Bethesda (301-435-7913); www.clinicaltrials.gov/ct/show/NCT00039663. (02-CC-0208)


Medical Marijuana for Peripheral Neuropathy

This study will assess whether smoked marijuana (cannabis) helps relieve pain related to peripheral neuropathy, a potential side effect of certain antiretroviral drugs. A recently completed pilot study showed that medical cannabis is effective for this indication; the current study will extend the research to a larger number of participants. Subjects will be housed at San Francisco General Hospital for seven days, where they will be randomly assigned to smoke either marijuana or placebo cigarettes three times daily. A heat/capsaicin (hot pepper) pain test will be administered at the beginning of the study and at the end of the inpatient stay. Participants who complete the study will be compensated $650.

Prospective participants must be at least 18 years of age and have painful HIV-related neuropathy. They must either not be taking antiretroviral medications or have been on stable therapy for at least the past eight weeks. They must have used marijuana on at least six occasions in the past, but not within the 30 days prior to study entry. There are no CD4 cell count or viral load requirements. Subjects may not have diabetes, uncontrolled high blood pressure, or heart or lung disease, and must not be using certain medications including corticosteroids. Current tobacco users are not eligible. Women may not be pregnant or breast-feeding.

The study will enroll 50 participants in San Francisco (415-476-9554 ext. 366); www.clinicaltrials.gov/ct/show/NCT00046722. (CC 056)


Can Herpes Suppression Prevent HIV?

The ACE study, conducted by the San Francisco Department of Public Health, will examine whether suppression of genital herpes (herpes simplex virus type 2, or HSV-2) with acyclovir (Zovirax) can help reduce the risk of contracting HIV. Research to date indicates that having even subclinical HSV-2 infection without obvious lesions can increase the likelihood that an individual will contract or transmit HIV. Participants will be randomly assigned to receive either 400 mg of acyclovir or placebo twice daily for 12 months. Those who develop genital herpes outbreaks will be treated with open-label acyclovir. Study visits will take place every month and participants will be compensated for their time.

Eligible participants are sexually active HIV-negative gay or bisexual men at least 18 years of age with confirmed HSV-2 infection.

The study will enroll 315 participants in New York City (212-388-0008), San Francisco (415-554-9064), and Seattle (206-521-5821).


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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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