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Clinical Trials

Summer 2008

Below is a list of selected currently enrolling clinical trials gathered from various sources.

The federal government's AIDSinfo website 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 Website (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).

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Most U.S. government HIV/AIDS treatment trials are conducted by the AIDS Clinical Trials Group (ACTG). HIV prevention trials fall under the auspices of the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN), and the Microbicide Trials Network (MTN). The other two trials networks funded by the National Institutes of Health are the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) and the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), the latter of which encompasses the former Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). The National Center for Complementary and Alternative Medicine (NCCAM) conducts trials of complementary therapies for all conditions, including HIV/AIDS.

TrialSearch, operated by the AIDS Community Research Initiative of America (ACRIA), is a searchable online database of clinical trials related to HIV/AIDS. CenterWatch is a commercial website that includes trial listings for all diseases, including HIV/AIDS and related conditions. Trials of new drugs sponsored by pharmaceutical companies are often listed on company websites as well as ClinicalTrials.gov.

Call the telephone numbers listed for each study or see the indicated websites for further 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
HIV Prevention Trials Network: www.hptn.org
HIV Vaccine Trials Network: www.hvtn.org
IMPAACT: http://pactg.s-3.com
INSIGHT: http://insight.ccbr.umn.edu
Microbicide Trials Network: www.mtnstopshiv.org
NCCAM: www.nccam.nih.gov/clinicaltrials


OPTIONS for Treatment-Experienced People

Drug resistance can limit the effectiveness of antiretroviral therapy for treatment-experienced patients, but the prospects for constructing a suppressive regimen have improved with the recent approval of new classes of anti-HIV drugs. ACTG A5241, also known as the OPTIONS study, is an open-label Phase III strategy trial designed to assess the efficacy of HAART regimens containing new drug classes, with or without nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).

Guided by resistance testing, participants will begin a new three- or four-drug regimen containing some combination of the CCR5 antagonist maraviroc (Selzentry), the integrase inhibitor raltegravir (Isentress), the fusion inhibitor enfuvirtide (T-20; Fuzeon), the new non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine (Intelence), and the protease inhibitors (PIs) darunavir (Prezista) and tipranavir (Aptivus) for 48 weeks. In addition, some patients will be randomly assigned to also include NRTIs. The primary outcome measure is time to regimen failure; the investigators will also assess secondary measures, including tolerability, adherence, cardiovascular risk, and quality of life.

Eligible participants must be at least 16 years of age and have experience with or resistance to three antiretroviral drug classes. They must have a viral load of at least 1,000 copies/mL and must be on a failing PI-containing HAART regimen with no changes for the prior eight weeks. Exclusion criteria include hepatitis B coinfection, serious illness requiring systemic therapy, certain laboratory abnormalities, and use of certain medications (including past use of integrase inhibitors). Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

The study aims to enroll 577 participants at more than 20 sites, including Aurora (303-724-0712), Baltimore (410-706-1476), Boston (617-632-7627), Chicago (312-942-4810), Cincinnati (513-584-8373), Durham (919-668-4847), Houston (713-500-6751), Los Angeles (323-343-8283), Memphis (901-495-3490), Nashville (615-467-0154 ext. 108), New York City (212-746-7198), Rochester (585-275-2740), San Diego (619-543-8080), San Francisco (415-514-0550 ext. 354), San Juan (787-765-4186), and Washington, DC (202-687-2294). www.clinicaltrials.gov/show/NCT00537394 (ACTG A5241).


Experimental Integrase Inhibitor: Elvitegravir

Gilead Science is sponsoring a Phase III trial comparing the safety, tolerability, and efficacy of ritonavir (Norvir)-boosted elvitegravir (GS 9137), its investigational once-daily integrase inhibitor, against twice-daily raltegravir, the first approved drug in this class. Treatment-experienced participants will be randomly assigned to receive one of the two integrase inhibitors added to an optimized background regimen containing a boosted PI. The primary endpoint is the proportion of patients who achieve and maintain a viral load less than 50 copies/mL through 48 weeks.

Eligible participants must be at least 18 years of age and have a viral load of at least 1,000 copies/mL. They must be on stable antiretroviral therapy for at least 30 days prior to study entry, and must have documented resistance or at least six months' experience with two or more different classes of antiretroviral agents. They must have a normal electrocardiogram (ECG), adequate kidney function, and normal liver function tests. Exclusion criteria include recent AIDS-defining conditions, prior use of integrase inhibitors, and current use of certain medications. Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

The study aims to enroll 700 participants at more than 80 sites, including Albany, Atlanta, Baltimore, Boston, Chicago, Dallas, Detroit, Durham, Ft. Lauderdale, Honolulu, Houston, Las Vegas, Little Rock, Los Angeles, Miami, Nashville, Newark, New Haven, New York City, Oakland, Orlando, Philadelphia, Phoenix, Sacramento, San Diego, San Francisco, San Juan, Santa Fe, St. Louis, and Washington, DC. For site-specific contact information, consult the trial website or call Andrew Plummer (650-522-6173; Andrew.Plummer@gilead.com). www.clinicaltrials.gov/ct2/show/NCT00707733 (GS-US-183-0144).


Vicriviroc for Treatment-Naive Patients

Schering-Plough has initiated a new clinical trial to study its investigational CCR5 antagonist vicriviroc in individuals starting antiretroviral therapy for the first time; the sole approved drug in this class, maraviroc, is indicated only for treatment-experienced patients. In this open-label study, participants with CCR5-tropic HIV (virus that uses the CCR5 coreceptor to enter CD4 cells) will be randomly assigned to receive either vicriviroc or tenofovir/emtricitabine (Truvada), both with ritonavir-boosted atazanavir (Reyataz). The primary outcome measure is mean change in HIV RNA after 48 weeks of therapy.

Eligible participants must be at least 18 years of age and have a viral load of at least 5,000 copies/mL, a CD4 count of at least 200 cells/mm3, and confirmed exclusively CCR5-tropic (not CXCR4-tropic or dual/mixed-tropic) HIV. They must be treatment-naive, with a maximum cumulative lifetime exposure to antiretroviral therapy of no more than four weeks, and none within the prior eight weeks. Exclusion criteria include abnormal laboratory tests, certain concurrent illnesses, and recent use of certain medications or vaccinations. Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

The study aims to enroll 200 participants at several U.S. and international sites, including the Bronx, Houston, Newark, Orlando, and Palm Springs. For site-specific contact information, call the Schering-Plough Clinical Trial Registry Call Center at 888-772-8734. www.clinicaltrials.gov/ct2/show/NCT00551018 (P04875).

In addition, two Phase III studies of vicriviroc in treatment-experienced patients are still enrolling participants at about 150 sites in the U.S., Canada, Central and South America, Europe, and South Africa; for details, see "Open Clinical Trials" in the Winter 2008 issue of BETA. www.clinicaltrials.gov/ct2/show/NCT00523211 (VICTOR-E3; P04405; 3553293) and www.clinicaltrials.gov/ct2/show/NCT00474370 (VICTOR-E4; P04889; 3547030).


Recent Infection: SETPOINT Study

A growing body of evidence supports treatment earlier in the course of chronic HIV infection, but the benefits and risks of antiretroviral therapy during primary or acute infection are unclear (see "When to Start Antiretroviral Treatment: A Changing Equation").

In the open-label ACTG A5217 or SETPOINT study, researchers will assess whether nine months of antiretroviral therapy during early infection can alter the eventual viral "set point," or stable viral load level. Newly infected participants will be randomly assigned either to start immediate treatment with twice-daily lopinavir/ritonavir (Kaletra) plus once-daily tenofovir/emtricitabine or to undergo observation without treatment for 36 weeks. At that point, all eligible subjects will be offered treatment continuation or initiation, and viral load and other parameters will be monitored through 96 weeks.

Eligible participants must be at least 18 years of age and recently infected with HIV. They must have a viral load greater than 500 copies/mL, a CD4 count of at least 350 cells/mm3, and a CD4 cell percentage of at least 14% within 21 days prior to study entry. Exclusion criteria include advanced HIV disease, history of pancreatitis or coronary artery disease, serious medical or psychiatric illness, prior use of antiretroviral drugs (not including post-exposure prophylaxis more than one year ago) or experimental HIV vaccines, and current use of certain medications. Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

The study aims to enroll 150 participants at nearly 40 sites, including Atlanta (404-616-6313), Boston (617-724-0070), Chapel Hill (919-843-8761), Chicago (312-695-5012), Columbus (614-293-8112), Denver (303-372-5535), Detroit (313-916-2570), Durham (919-684-8216), Greensboro (336-832-7888), Indianapolis (317-274-8456), Los Angeles (310-423-3755), Miami (305-243-3838), New York City (212-327-7281), Philadelphia (215-349-8092), Providence (401-793-4971), 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/ct2/show/NCT00090779 (ACTG A5217; AIEDRP AIN503).


HAART During Acute Infection

A related study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) will assess whether a one-year course of treatment administered during acute infection can slow HIV disease progression. In this open-label trial, participants will be randomly assigned to receive combination antiretroviral therapy for one year (specific regimens to be determined on an individual basis) or to undergo observation without treatment. Viral load and CD4 cell count will be assessed 24 and 36 months after initial presentation.

Eligible participants must be at least 18 years of age and have documented acute or recent HIV infection (within the past 12 months). They must have a CD4 cell count of at least 350 cells/mm3 and a viral load of at least 5,000 copies/mL. Exclusion criteria include serious illnesses, prior use of antiretroviral drugs (except post-exposure prophylaxis) or experimental HIV vaccines, and recent use of certain medications. Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

This study has a target enrollment of 180 participants at Johns Hopkins University in Baltimore (410-614-7796), CHUM-Hotel-Dieu in Quebec, Canada (514-890-9000), Sunnybrook Health Sciences Center in Toronto, Canada (416-465-7936), and the University of British Columbia in Vancouver, Canada (604-642-6429). www.clinicaltrials.gov/ct2/show/NCT00106171 (1R01AI056990-01A1).


Mindfulness-Based Stress Reduction

Mindfulness-based stress reduction (MBSR), which employs mental training practices such as meditation to focus awareness, is one of several methods used to manage stressful or traumatic experiences (see "Trauma: Frozen Moments, Frozen Lives"). Two NCCAM studies are looking at MBSR in people with HIV, one for individuals not taking antiretroviral therapy, the other for patients dealing with antiretroviral side effects.

The Phase II Staying Well study aims to determine whether MBSR is associated with slower HIV disease progression, reduced depression, and improved quality of life in untreated individuals; it will also assess whether MBSR influences neuroendocrine and immune function. Participants will be randomly assigned to take part in either MBSR training or general health education workshops; both groups will attend eight weekly sessions at the University of California at San Francisco (UCSF) Osher Center for Integrative Medicine.

Eligible participants 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 of at least 100 copies/mL and a CD4 cell count above 250 cells/mm3 at study entry. They should not plan to start treatment during the next 12 months, but may do so if medically necessary. Exclusion criteria include previous MBSR training or current practice and use of certain medications (including recently started psychiatric drugs). The study has a target enrollment of 330 participants in San Francisco (415-353-9745; moranp@ocim.ucsf.edu). www.clinicaltrials.gov/show/NCT00271856 (AT002024).

A related study will explore the effect of MBSR on the experience of drug-related side effects in individuals taking antiretroviral therapy. This trial also involves an eight-week training program at the Osher Center. Participants randomly assigned to start the training immediately upon study enrollment will be compared with those on a waiting list to join the program later. The primary outcome will be frequency of and distress associated with antiretroviral side effects, with secondary outcomes of quality of life and medication adherence.

Eligible participants must be at least 18 years of age and able to speak English. They must have been on antiretroviral therapy for at least 30 days and must be experiencing significant side effect-related "bother" as determined by a standard symptom distress scale. Exclusion criteria include severe cognitive impairment, active psychosis, active substance abuse, and current participation in another MBSR or adherence/coping intervention program. The study aims to recruit 100 participants in San Francisco (415-597-9374; mallory.johnson@ucsf.edu). www.clinicaltrials.gov/show/NCT00312936 (R21AT003102-01).

A trial of cognitive behavioral therapy using guided imagery to help alleviate antiretroviral therapy side effects will also soon begin enrolling participants at Penn State Milton S. Hershey Medical Center in Hershey, PA. The study is open to participants experiencing drug-related nausea, pain, fatigue, or anxiety. For further information, contact Eric Doerfler (717-948-6513; red1012@psu.edu) or Linda Goodfellow (412-396-6548l goodfellow@duq.edu). www.clinicaltrials.gov/ct2/show/NCT00696839 (#08-17).




  
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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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