New and ongoing clinical research studies
at the VCU HIV/AIDS Center

General studies involving therapy of persons living with HIV

INSIGHT 001: START
Strategic timing of anti-retroviral therapy

The purpose of this randomized study is to determine in persons with a CD4+ cell count > 450/mm3 whether immediate initiation of highly-active antiretroviral therapy (HAART) is superior to deferral of HAART until the CD4+ cell count declines to 325 cells/mm3 or until symptoms develop. Sponsored by the National Institutes for Health (NIH). Status: Will begin enrolling around October 2007 at the VCU Medical Center (Richmond, Va.), the Eastern Virginia Medical School (Norfolk, Va.), and the McGuire VA Hospital (Richmond, Va.). Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

CPCRA 066: Genomics
Collection and use of blood for genetic and other related analyses

Description: The purpose of this study is to obtain a whole blood sample to archive for use in future studies investigating associations between human genetic factors and clinical data collected in qualifying CPCRA studies for the purpose of addressing questions related to HIV-infection or conditions relevant to the health of persons with HIV-infection. This study is open to enrollment. Sponsored by the National Institutes for Health (NIH). Status: Enrolling patients now (only patients enrolled in past CPCRA studies and SMART eligible). Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, PhD is the Principle Investigator for the site.

CPCRA 065: The SMART Study
A large, simple trial comparing two strategies for management of anti-retroviral therapy

The purpose of this study is to compare the long-term clinical consequences of two strategies of antiretroviral (AR) management: the drug conservation (DC) strategy, a strategy aimed at conserving drugs through episodic use of antiretroviral treatment for the minimum time to maintain CD4+ cell count >= 250 cells/mm3 versus the viral suppression (VS) strategy, a strategy aimed at suppressing viral load as much as possible, immediately following randomization and throughout follow-up, irrespective of CD4+ cell count. This study is closed to accrual, patients are in followup. Sponsored by the National Institutes for Health (NIH). Status: closed to enrollment, patients are in followup. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

CPCRA 060: Long-term monitoring
A prospective study of long-term clinical, virologic and immunologic outcomes in HIV-infected individuals

This study is designed to provide a mechanism for long-term monitoring of:

  • Participants currently or previously enrolled in qualifying randomized trials of HIV treatment or management strategies.
  • Antiretroviral-naive patients starting treatment outside a qualifying CPCRA trial.
  • Antiretroviral-naive patients electing to defer treatment.

This study is closed to accrual, patients are in follow-up. Sponsored by the National Institutes for Health (NIH). Status: closed to enrollment, patients are in follow-up. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

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Studies involving immune system enhancement in persons with HIV

ESPRIT 002: STALWART
Evaluation of subcutaneous proleukin (IL-2) in ART naïve patients with CD4+ t-cell counts >350

STALWART is a randomized, international, study of interleukin-2 (IL-2) in people with HIV infection and a CD4+ cell count of at least 350/mm3. The goal of the study is to evaluate and compare the effectiveness of IL-2 alone versus IL-2 plus with brief use of anti-HIV therapy versus no treatment in delaying CD4+ cell count decline and need for continuous anti-HIV therapy.  Sponsored by the National Institutes for Health (NIH). Status: enrolling now at the VCU Medical Center (Richmond, Va.). Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

ESPRIT 001
Evaluation of subcutaneous proleukin (IL-2) in a randomized international trial

ESPRIT is a randomized, international, 5-year, 4,000-person study of interleukin-2 (IL-2) in people with HIV infection and a CD4+ cell count of at least 300/mm3. The goal of study is to evaluate and compare the effectiveness of IL-2 plus anti-HIV therapy versus anti-HIV therapy alone, on numbers and severity of AIDS-related illnesses and deaths over a five year period. Sponsored by the National Institutes for Health (NIH). Status: closed to enrollment, patients are in follow-up. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

SILCAAT
Evaluation of subcutaneous proleukin (IL-2) in a randomized international trial

SILCAAT is a randomized study of interleukin-2 (IL-2) in people with HIV infection and a CD4+ cell count of less than 300/mm3. The goal of study is to evaluate and compare the effectiveness of IL-2 plus anti-HIV therapy versus anti-HIV therapy alone on numbers and severity of AIDS-related illnesses and deaths. Sponsored by Chiron. Status: closed to enrollment, patients are in follow-up. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

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Studies involving persons with drug-resistant HIV

IMPACT (sponsored by BMS)

Purpose: evaluate the 150L substitution among subjects experiencing virologic failure on a HAART regimen containing Atazanavir. This is a one time blood draw but the subject must still be taking Atazanavir when this is done. Status: enrolling now at the VCU Medical Center (Richmond, Va.). Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

Raltegravir (MK-0518) expanded access program (sponsored by MERCK)

Purpose: to provide highly ART experienced (generally fairly drug resistant) patients with limited to no treatment options in early access of MK-0518 (an HIV- integrase inhibitor) in combination with an optimized background ART.  Status: enrolling now at the VCU Medical Center (Richmond, Va.). Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

Etravirine (TMC125) expanded access program (sponsored by Tibotec)

Purpose: to provide early access to TMC125 (a second generation NNRTI) to HIV-1 infected subjects who have failed multiple ARV regimens. To be eligible subjects would be failing their current ARV regimen or be on a treatment interruption, should have previously received two different protease inhibitor containing regimens and be at least 3-class experienced with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background or additional ARVs from a list of allowed medications. Status: enrolling now at the VCU Medical Center (Richmond, Va.).  Contact Vinnie Mitchell at 828-6471. Daniel Nixon DO, Ph.D. is the principle investigator for the site.

Maraviroc (UK427, 857) expanded access program (sponsored by Pfizer)

Purpose: to provide early access of Maraviroc (UK427, 857). It is an experimental medication being developed for use in combination with other ARV medications for the treatment of HIV-1, treatment experienced patients with virus susceptible to it (example: HIV-1 that exclusively uses the chemokine co-receptor CCR5 for cell entry). This is an open-label, non-comparative, international phase 3b safety study of Maraviroc in HIV positive, treatment-experienced patients with R5 HIV who have limited therapeutic options. The CCR5/MARAVIROC EAP is only available at Cross-Over Health Center.  Please contact Patricia Dodson, R.N. at (804) 828-3436 for information. Vivian Bruzzese M.D. is the principle investigator for the site.

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Studies involving liver disease or hepatitis in HIV infected persons

HIV-HCV Coinfection: impact on immune dysfunction

Purpose: to study the natural history of HCV disease progression in those living with HIV. Sponsored by the National Institutes for Health (NIH). Status: open to enrollment. Contact (804) 828-4060. Richard Sterling MD, MS is the principle investigator.

A randomized, multicenter, double blinded, Phase IV study comparing the safety and efficacy of Pegasys® 180µg plus Copegus® 1,000 or 1,200 mg to the currently approved combination of Pegasys® 180µg plus Copegus® 800 mg in interferon-naive patients with chronic hepatitis C genotype 1 virus infection coinfected with HIV-1.

Purpose: Compare two treatment strategies in patients with hepatitis C coinfected with HIV. Sponsored by Hoffmann-La Roche Inc. Status: open to enrollment. Contact (804) 828-4060. Richard Sterling MD, MS is the principle investigator for the site.

Relationship of metabolic abnormalities to hepatic steatosis in HIV

Purpose: To define the spectrum of NAFLD in HIV infected patients with abnormal liver enzymes in the absence of HCV and HBV. Sponsored by the National Institutes for Health (NIH). Status: open to enrollment. Contact (804) 828-4060. Richard Sterling MD, MS is the principle investigator.

Pharmacokinetics of efavirenz in patients with chronic liver disease

Purpose: to study the effect of liver disease on blood levels of the HIV drug efavirenz.  Sponsored by BMS. Status: open to enrollment. Contact (804) 828-4060. Richard Sterling MD, MS is the principle investigator for the site.

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Studies involving mental health, substance abuse and spirituality in persons living with HIV

How well does spirituality predict health status in people living with HIV/AIDS?

Purpose: this exploratory study will use a model building approach to examine the relationship between spirituality and health status in people living with HIV/AIDS. Participants will be requested to complete seven questionnaires, which will take approximately 45 minutes. Status: open to enrollment. Contact Rachel Cobb, BSN, MDiv, R.N. at (804) 386-2675. Inez Tuck, Ph.D., MBA, R.N. is the principle investigator

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Studies involving HIV or treatment related complications

A multicenter randomized, double-blind, controlled study of NGX-4010 for the treatment of painful HIV associated neuropathy (Neurogesx, Inc.)

Purpose: The study uses Capsaicin and it is a high dose versus standard strength (OTC cream). It is applied to the feet during one office visit and the patients are followed for three months after to assess the ongoing relief of pain. More information is available at www.clinicaltrials.gov. To enroll in this study, patients need to be on stable pain medicines coming in to the study and they may not have started or stopped treatment with one or more neurotoxic antiretroviral agents (i.e. didanosine) for two months prior to treatment application. Mike Climo MD is the site principal investigator. Contact Chris Harper at (804) 675-5458 for information.

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AIDS clinical trial group studies

Coming soon…