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Open Clinical Trials

Winter/Spring 2009

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).

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.

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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: http://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
IMPACT: http://pactg.s-3.com
INSIGHT: http://insight.ccbr.umn.edu
Microbicide Trials Network: www.mtnstopshiv.org
NCCAM: www.nccam.nih.gov/clinicaltrials

Rilpivirine (TMC278) for Treatment-Naive Patients

Tibotec Pharmaceuticals has started two Phase III clinical trials to study TMC278 (rilpivirine), its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in patients new to antiretroviral therapy. Data from an earlier Phase IIb study showed that after 96 weeks, 73% of patients taking a HAART regimen containing rilpivirine (at doses of 25, 75, or 150 mg) maintained virological suppression below 50 copies/mL, compared with 71% of those taking efavirenz (Sustiva). An injectable nanoformulation of rilpivirine is also under study (see "Drug Watch," page 21).

Study TMC278-TiDP6-C209 (ECHO) will evaluate the efficacy, safety, and tolerability of 25 mg once-daily oral rilpivirine versus 600 mg once-daily efavirenz, each combined with tenofovir plus emtricitabine (the Truvada fixed-dose coformulation pill). In study TMC278-TiDP6-C215 (THRIVE), participants will be randomly assigned to receive the same doses of rilpivirine or efavirenz, but will use one of three investigator-chosen nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbones: tenofovir plus emtricitabine, abacavir plus 3TC (the Epzicom fixed-dose pill), or AZT plus 3TC (the Combivir fixed-dose pill). Both studies will assess antiviral activity (proportion of patients with HIV RNA below 50 copies/mL at 48 weeks), immunological changes, safety parameters, adherence, and viral genotypic and phenotypic changes over 96 weeks.

For both studies, prospective participants must be at least 18 years of age, have a viral load of at least 5,000 copies/mL, and be starting antiretroviral therapy for the first time. Patients must have virus sensitive to the two NRTIs chosen for treatment, and those receiving abacavir must have a negative HLA-B*5701 screening test. Exclusion criteria include any prior use of antiretroviral drugs, documented NNRTI resistance mutations, advanced AIDS, active tuberculosis, and impaired kidney function.

Both studies aim to enroll 680 participants at more than 120 sites, including Albany, Albuquerque, Baltimore, Birmingham, Boston, Chapel Hill, Chicago, Cincinnati, Dallas, Detroit, Houston, Los Angeles, Miami, Milwaukee, Minneapolis, Newark, New York City, Orlando, Philadelphia, Phoenix, Rochester, Sacramento, San Diego, San Francisco, Seattle, Tampa, Washington, DC, and international locations throughout the world. To determine your eligibility and find the nearest trial site, visit http://host.veritasmedicine.com/index.cfm?vip=1913-872-252200 (for TMC278-TiDP6-C209) or http://host.veritasmedicine.com/index.cfm?vip=1913-872-252200&sid=16616 (for TMC278-TiDP6-C215). www.clinicaltrials.gov/ct2/show/NCT00540449 (TMC278-TiDP6-C209, CR002689); www.clinicaltrials.gov/ct2/show/NCT00543725 (TMC278-TiDP6-C215, CR002704).

Once-Daily Raltegravir for Treatment-Naive Patients

The first HIV integrase inhibitor, raltegravir (Isentress), was approved in October 2007 for twice-daily administration in treatment-experienced patients. Merck is now testing the drug as a once-daily option for people starting antiretroviral therapy for the first time. In the Phase III QDMRK trial, participants will be randomly assigned to receive either 800-mg once-daily or 400-mg twice-daily raltegravir, both in combination with tenofovir/emtricitabine (Truvada coformulation). The study will assess the proportion of patients with HIV RNA below 50 and below 400 copies/mL at 48 and 96 weeks, along with CD4 cell count increases and various safety parameters.

Eligible participants must be at least 18 years of age. They must be treatment-naive and may not have received any antiretroviral agent for seven or more days. Exclusion criteria include documented resistance to tenofovir or emtricitabine, current use of recreational drugs, and recent history of drug or alcohol abuse or dependence. Women may not be pregnant or breastfeeding.

The study aims to enroll 750 participants in 21 countries. U.S. sites include Beverly Hills, Dallas, Denver, Houston, Los Angeles, Miami, and San Juan, Puerto Rico. For further information or to enroll, call toll-free 888-577-8839. More details are available at Merck's clinical trials website, www.benchmrk.com (click on QDMRK). www.clinicaltrials.gov/ct2/show/NCT00745823 (2008_543, MK0518-071).

Can Raltegravir Further Reduce Viral Load?

Research suggests that even low-level ongoing HIV replication may have detrimental effects. A set of studies is exploring whether raltegravir (Isentress) can further suppress viral load when added to an NNRTI- or protease inhibitor-based regimen in patients who have undetectable HIV RNA using standard tests.

In the first Phase I study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), participants with suppressed viral load will be randomly assigned to add raltegravir (400 mg twice daily) or placebo to their current regimen containing an NNRTI or protease inhibitor; after 12 weeks, participants will cross over to the opposite arm. Viral load will be measured using a polymerase chain reaction test with a limit of detection of 1 copy/mL. CD4 cell count, CD4 and CD8 cell activation, and adverse events will be assessed at weeks 12 and 24.

Eligible participants must be at least 18 years of age and have a CD4 count of at least 200 cells/mm3. They must have been on antiretroviral therapy containing at least two NRTIs and either an NNRTI or a ritonavir-boosted protease inhibitor for at least 12 months, with no changes for at least three months. They must have a viral load below the limit of quantification for at least six months, including a measurement below 50 copies/mL using the Roche Amplicor HIV-1 RNA Ultrasensitive assay within 60 days of study entry. Exclusion criteria include previous virological failure while on an antiretroviral regimen, certain medical conditions and abnormal laboratory tests, active alcohol or drug abuse, and recent use of immunosuppressive medications or vaccines. Women may not be pregnant or breastfeeding.

The study aims to enroll 50 participants in Atlanta (404-616-6313), Birmingham (205-975-7925), Boston (617-724-0072), Chicago (312-695-5012), Cleveland (216-778-5489), Greensboro (336-832-7888), Los Angeles (310-222-3848), New York City (212-746-7198), Philadelphia (215-349-8092), Pittsburgh (412-647-0771), Rochester (585-275-2740), San Francisco (415-514-0550 ext. 354), Stanford (650-723-2804), and St. Louis (314-454-0058). www.clinicaltrials.gov/ct2/show/NCT00515827 (ACTG A5244).

Related studies looking at treatment intensification with raltegravir are being conducted at San Francisco General Hospital (415-476-4082 ext. 122) and San Francisco Veterans Affairs Medical Center (415-476-4082 ext. 122) www.clinicaltrials.gov/ct2/show/NCT00631449 (H52899-31393-01); the University of Pittsburgh (412-647-6710) www.clinicaltrials.gov/ct2/show/NCT00618371 (27XS050); and the National Jewish Medical and Research Center in Denver (303-398-1552). www.clinicaltrials.gov/ct2/show/NCT00738569.

Maraviroc for CD4 Cell Recovery

Maraviroc, the first CCR5 antagonist, was approved in August 2007 for use by treatment-experienced patients. The drug works by blocking one of the two coreceptors HIV uses to enter cells. In this Phase IV pilot study, investigators will test the hypothesis that maraviroc has protective immunomodulatory effects independent of HIV replication -- specifically, that it may reduce persistent inflammation and T cell activation that interferes with expected immune reconstitution in patients taking HAART. Participants on antiretroviral therapy with undetectable viral load will add twice-daily maraviroc or placebo for 24 weeks. HIV RNA will be measured using a test with a limit of detection of 1 copy/mL, and various markers of immune activation will be assessed.

Eligible participants must be at least 18 years of age. They must have been on stable antiretroviral therapy for at least 12 months with better than 90% adherence for the preceding 30 days. They must have a CD4 count below 350 cells/mm3 and have a viral load less than 50 copies/mL. Exclusion criteria include prior use of CCR5 antagonists, a CD4 cell increase of more than 100 cells/mm3 during the past year, serious illnesses, active hepatitis B or C requiring treatment, certain abnormal laboratory values, and recent use of immunomodulatory drugs. Women must not be pregnant or breastfeeding and must agree to use barrier contraception.

The study aims to enroll about 40 participants at the University of California at San Francisco (415-476-4082 ext. 345), Stanford University (650-723-2804), Rush University Stroger Hospital in Chicago (312-864-4573), and Case Western Reserve University in Cleveland (312-864-4573). www.clinicaltrials.gov/ct2/show/NCT00735072 (GA9001DE).

NIAID will soon begin a related study of maraviroc in patients with suboptimal CD4 cell recovery despite sustained virological suppression; check the website for inclusion/exclusion criteria and locations. www.clinicaltrials.gov/ct2/show/NCT00709111 (ACTG A5256).

Vicriviroc in People With Dual/Mixed-Tropic HIV

Vicriviroc is an investigational CCR5 antagonist being developed by Schering-Plough. It has demonstrated potent antiviral activity in treatment-experienced patients with exclusively CCR5-tropic HIV. In this Phase II study, researchers will assess the efficacy and safety of vicriviroc in people with dual-tropic or mixed-tropic virus that can use both CCR5 and CXCR4 coreceptors. Treatment-experienced patients with extensive drug resistance who are failing on their current regimen will be randomly assigned to add 30 mg once-daily vicriviroc or placebo plus optimized background therapy for 48 weeks.

Eligible participants must be at least 16 years of age and have dual/mixed CCR5/CXCR4-tropic HIV. They must have taken antiretroviral therapy for at least six months or have documented resistance to at least two of the major antiretroviral drug classes (NRTIs, NNRTIs, or protease inhibitors), and must be experiencing treatment failure on their current regimen as indicated by HIV RNA greater than 1,000 copies/mL. Exclusion criteria include a CD4 count below 200 cells/mm3, history of malignancies, and any condition likely to increase the risk of seizures.

The study aims to enroll 150 participants in Los Angeles, Newark, New York City, Orlando, Vero Beach, San Juan, Puerto Rico, and several sites in Latin America. For further information or to enroll, call the Schering-Plough Clinical Trial Registry Call Center toll-free at 888-772-8734. www.clinicaltrials.gov/ct2/show/NCT00551330 (P05057).

Cognitive Function in Older People With HIV

The Memory and Aging Center at the University of California at San Francisco (UCSF) is conducting a longitudinal observational study to evaluate cognitive abilities in HIV positive individuals age 40 years or older. Participants will have two initial visits, one for neuropsychological and cognitive testing, and one for brain magnetic resonance imaging (MRI); cognitive tests will be repeated annually for at least five years.

Eligible participants must be HIV positive, at least 40 years of age, and on stable antiretroviral therapy for three months with no plans to change their regimen in the near future. Exclusion criteria include past brain opportunistic infections, major neurological or psychiatric illness, and alcohol or substance abuse or dependence.

The study will be conducted at UCSF in San Francisco. For further information or to enroll, contact Victor Valcour (415-476-1895 or vvalcour@memory.ucsf.edu) or Alefiyah Pishori (415-476-3722 or apishori@memory.ucsf.edu).

Nutritional Supplement for Insulin Resistance

A Phase I/II study sponsored by the National Center for Complementary and Alternative Medicine will assess whether use of the nutritional supplement chromium picolinate can help reduce insulin resistance or glucose intolerance -- a precursor to diabetes -- in people with HIV. Previous research suggests that chromium picolinate helps improve insulin sensitivity in HIV negative individuals with type 2 diabetes mellitus. Participants will be randomly assigned to receive either chromium picolinate or placebo once daily for eight weeks. There will be four overnight visits plus two additional daytime visits.

Eligible participants must be at least 18 years of age and currently taking combination antiretroviral therapy. They must have a CD4 cell count of at least 300 cells/mm3 and HIV viral load below 35,000 copies/mL. Exclusion criteria include certain abnormal laboratory tests and medical conditions, including cancer, untreated hypertension, and untreated hepatitis. Women may not be pregnant.

This study will enroll 40 participants at the State University of New York General Clinical Research Center in Stony Brook (631-444-1175 or 631-444-3740). www.clinicaltrials.gov/ct/show/NCT00109746 (AT002499-01A1).

Lifestyle Modification and Metformin for Metabolic Syndrome

A study sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases will assess the benefits of lifestyle modification and metformin (Glucophage) in HIV positive people with metabolic syndrome. Participants will be randomly assigned to participate in a diet and exercise program, take metformin, or both. Investigators will assess carotid intima media thickness (a marker for atherosclerosis) and various metabolic and inflammatory parameters.

Prospective participants must be 18 to 65 years of age and on stable antiretroviral therapy for more than six months. They must have metabolic syndrome as defined by the National Cholesterol Education Program based on waist circumference, blood pressure, and blood lipid and glucose levels. Exclusion criteria include new serious opportunistic infections, recent weight loss of greater than ten pounds, history of unstable angina or other contraindications to exercise, use of insulin or other antidiabetes drugs, current alcohol or substance abuse, certain laboratory abnormalities, and use of certain medications. Women may not be pregnant or breastfeeding.

The study aims to enroll 200 participants at Massachusetts General Hospital in Boston (617-724-9109). www.clinicaltrials.gov/ct2/show/NCT00399360 (DK-49302-10AR).

Vaginal Microbicides

Most large-scale trials of microbicides for HIV prevention take place in developing countries with a high rate of HIV incidence. However, a few studies looking at vaginal microbicide use are enrolling participants in the U.S. CONRAD and NIAID are conducting a Phase I safety study of UC-781, an investigational NNRTI vaginal gel microbicide. Investigators will assess the persistence of 0.1% UC-781 gel in the vagina and systemic absorption following a single application for up to eight hours.

Eligible participants must be 18 to 45 years of age, HIV negative, and in general good health. They must agree to remain sexually abstinent during parts of the study. Exclusion criteria include menopause, hysterectomy, latex allergy, use of certain medications, and pregnancy or breastfeeding.

The study aims to enroll 60 participants at the University of Pittsburgh Medical Center (412-641-4242). www.clinicaltrials. gov/ct2/show/NCT00441909 (U19-AI051661).

Another study soon to begin enrollment at the same site will look at maternal blood levels and placental transfer of tenofovir in HIV negative women who receive a single administration of an investigational 1% tenofovir vaginal gel two hours prior to Cesarean delivery. See the website for inclusion/exclusion criteria and locations. www.clinicaltrials.gov/ct2/show/NCT00540605 (U01-AI068633-0, MTN-002).

A related NIAID study will assess immune system markers and changes in antimicrobial activity of cervicovaginal secretions from HIV negative women who receive multiple applications of 1% tenofovir gel. The trial will take place at Montefiore Medical Center at the Albert Einstein College of Medicine in the Bronx. www.clinicaltrials.gov/ct2/show/NCT00594373 (U01-AI069551, TFV 010).

The Microbicide Trials Network is conducting a Phase I study of the safety and acceptability of 3% SPL7013 vaginal gel (VivaGel) in sexually active young women, with study sites at the University of South Florida in Tampa and the University of Puerto Rico in San Juan (MTN-004). For more information about this and other open MTN trials, see www.mtnstopshiv.org/node/studies.

Want to read more articles in the Winter/Spring 2009 issue of BETA? Click here.




  
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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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