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Open Clinical Trials

Summer/Fall 2010

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Acute HIV Infection

A study sponsored by the University of North Carolina at Chapel Hill will investigate the safety and tolerability of combination antiretroviral therapy started during acute HIV infection. Findings will inform the ongoing debate about "test-and-treat," a strategy of voluntary universal HIV testing followed by prompt treatment initiation for everyone found to be infected. Prior research indicates that people treated during very early infection may have a lower viral load set-point and slower disease progression.

People enrolled in this single-arm, non-randomized Phase IV pilot study will take the once-daily Atripla combination pill (tenofovir/emtricitabine/efavirenz) and will participate in a treatment adherence support program. Investigators will evaluate safety parameters and antiviral efficacy (viral load in plasma, cerebrospinal fluid and semen or vaginal secretions) over two years. They will also assess the prevalence of genotypic and phenotypic drug resistance mutations.


Eligible participants must be at least 18 years of age and be diagnosed with acute HIV infection. Exclusion criteria include active AIDS-defining illness, serious medical conditions, acute hepatitis, certain laboratory abnormalities (including evidence of kidney impairment), use of kidney-toxic drugs and certain other medications and recent use of experimental therapies or immune-modulating agents. Women may not be pregnant or breastfeeding and must use two effective forms of contraception.

The study will enroll 90 people in Chapel Hill and Durham, at sites participating in the Duke-UNC Acute HIV Infection Study Consortium (919-966-8533). (CID 0805, PHI 02).

CNS-Targeted ART

Despite the widespread use of effective ART, many people with HIV continue to develop neurocognitive problems. This may be due in part to antiretroviral drugs that fail to penetrate the blood-brain barrier and enter the central nervous system (CNS), or brain and spinal cord (see "HIV and the Brain," BETA, Summer/Fall 2009).

This Phase II/III study, sponsored by the University of California at San Diego, will evaluate the effectiveness of CNS-targeted ART regimens compared with non-targeted therapy. While smaller studies have observed better neurocognitive outcomes with targeted therapy, this randomized clinical trial will provide the level of evidence needed to formulate ART guidelines that take into account neurocognitive impairment.

The targeted strategy will involve initial selection of drugs known to penetrate the brain, with modification of the regimen if pharmacokinetic testing shows low drug exposure. People in the control arm will receive standard ART intended to suppress plasma viral load.

Eligible participants must be at least 18 years of age and have measurable HIV-related neurocognitive impairment. They must be willing to undergo at least three lumbar punctures (spinal taps) to collect cerebrospinal fluid. Exclusion criteria include serious illness, neurological disorders that could cause neurocognitive impairment, severe psychiatric disorders and recent use of immune-modulating agents or experimental drugs or vaccines. Women may not be pregnant.

The study aims to enroll 120 participants in Baltimore (443-287-8341), New York City (212-241-0352), San Diego (619-543-8080), San Francisco (415-206-4328) and St. Louis (314-747-1096). (060154, R01 MH58076).

Vitamin D Supplementation

Several recent studies have shown that people with HIV often have low vitamin D levels and are at risk for bone loss and subsequent fractures (see "Bone Loss Common, Screening Advised," in this issue).

This non-randomized, uncontrolled study, sponsored by the University of California at Los Angeles, will assess the prevalence of vitamin D deficiency in HIV positive people on ART, and will evaluate the safety and efficacy of supplementation.

All participants will receive 50,000 IU of vitamin D twice weekly for five weeks, followed by a 2,000-IU once-daily maintenance dose through week 12. At that point, vitamin D levels will be measured and patients who remain deficient may undergo a second period of supplementation through week 24. Investigators will measure HIV viral load, CD4 cell count, cholesterol, glucose and other metabolic parameters at baseline and after six months of vitamin D supplementation.

Eligible participants must be 18 to 90 years of age and on suppressive ART with viral load below 200 copies/mL. They will have received vitamin D screening within 90 days of study entry. Exclusion criteria include current use of vitamin D supplements (above the 400 IU dose in a standard daily multivitamin).

The study aims to enroll 140 participants receiving primary care at the UCLA CARE Center in Los Angeles (310-557-9062).

Tesamorelin and Growth Hormone

Human growth hormone and growth hormone-releasing factor have both been shown to reduce abdominal fat accumulation in people living with HIV. Tesamorelin (Egrifta), a synthetic growth hormone-releasing factor, was recently approved by the U.S. Food and Drug Administration (see "Tesamorelin Approved for Lipodystrophy," in this issue, for information on the approval, and "Drug Watch: Tesamorelin Update," in this issue, for background information).

This open-label Phase II trial, sponsored by Massachusetts General Hospital, will examine the short-term effects of two different doses of growth hormone, compared with tesamorelin, on brain secretion of growth hormone and glucose metabolism, testing the hypothesis that tesamorelin will have a less detrimental effect on insulin sensitivity. Participants will be randomly assigned to receive once-daily injections of recombinant growth hormone (6 mcg/kg or 2 mg regardless of body weight) or tesamorelin for two weeks.

Participants must be 18 to 60 years of age and on a stable ART regimen for at least 12 weeks. They must show evidence of body shape changes during HIV treatment, including increased abdominal girth, loss of limb fat, or facial lipoatrophy. Men should have a waist circumference of at least 95 cm and waist-to-hip ratio of at least 0.94; for women, 94 cm and 0.88, respectively. Exclusion criteria include severe chronic illness or cancer, carpal tunnel syndrome (a potential side effect of growth hormone), certain laboratory abnormalities and recent use of anti-diabetic drugs, steroids, or hormones (including hormonal contraceptives). Women may not be pregnant.

The study aims to enroll 36 participants at Massachusetts General Hospital in Boston (617-726-5312). (DK63639A, R01DK063639).

Atorvastatin for Atherosclerosis

HIV-positive people on ART have been shown to be at greater risk for cardiovascular disease compared with the general population. This study will assess whether using a statin drug reduces development and progression of atherosclerosis ("hardening of the arteries") and its associated inflammatory changes (for more information see "Inflammation, Immune Activation and HIV," BETA, Winter/Spring 2010).

The study, sponsored by Massachusetts General Hospital, will enroll participants with early coronary artery disease. They will be randomly assigned to take atorvastatin (Lipitor) or placebo once-daily for 12 months. Investigators will measure coronary and aorta plaque inflammation, function of the endothelial lining of blood vessels, lipid and fat hormone levels and C-reactive protein (an inflammation biomarker).

Participants must be 18 to 60 years of age and on a stable ART regimen for more than six months. They must have signs of subclinical coronary artery disease, defined as a CT scan showing one or more plaques, but no clinically significant artery blockage or history of cardiac symptoms (such as angina) or events (such as heart attack or stroke); in addition, they must have an LDL ("bad") cholesterol level of 70-130 mg/dL. Exclusion criteria include acute coronary conditions, recent infections, current statin use, certain laboratory abnormalities and recent significant radiation exposure. Women may not be pregnant or breastfeeding.

The study aims to enroll 40 participants at Massachusetts General Hospital in Boston (617-724-9109). (2008-P-000257, R01HL095123, HL 095123).

Acute Hepatitis C

A substantial proportion of people with HIV are coinfected with hepatitis C virus (HCV), including gay and bisexual men with apparently sexually transmitted HCV. Studies show that liver disease progression may be faster in people who acquire acute HCV infection when they are already HIV positive (see "Rapid Liver Disease Progression," in this issue), and coinfected individuals tend to respond more poorly to hepatitis C treatment.

This non-randomized, open-label Phase IV trial, sponsored by the University of California at San Francisco, will assess the benefits of hepatitis C treatment started during the first six months after acquiring HCV. Participants will start combination therapy using 180 mcg/week pegylated interferon alfa-2a (Pegasys) plus 1,000-1,200 mg/day weight-adjusted ribavirin. Pegylated interferon will be taken for 24 weeks; ribavirin will be used for either 12 or 24 weeks, depending on early response. Investigators will evaluate sustained virological response (SVR), or undetectable HCV RNA, 24 weeks after completion of therapy.

Participants must be at least 18 years of age and HIV positive. They must have newly acquired HCV within the past six months and have detectable HCV RNA at study entry. Exclusion criteria include uncontrolled depression (which may be worsened by interferon) and other serious liver disease. Women may not be pregnant.

The study will enroll 20 participants at San Francisco General Hospital (415-476-4082 ext. 313 or 556).

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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.
See Also
Specific U.S. Nationwide Studies


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