Prevention & Anti-Viral Studies
Study Name	Description	Inclusion Criteria*	Exclusion Criteria*
FIRST: CPCRA 058 Download the PDF Document	The purpose of this study is to determine whether it is better to start antiretroviral treatment with a PI-containing regimen, an NNRTI-containing regimen, or a PI plus NNRTI-containing regimen in NNRTI- and PI-naïve, HIV-infected patients. Some study medications will be provided by the sponsor	Willingness to start antiretroviral treatment that may include PI(s) and/or NNRTI	Previous PI or NNRTI useNRTI use for greater than 4 weeks or 3TC use for greater than 1 week
METABOLIC: CPCRA 061	This sub-study of CPCRA 058 FIRST compares the three different treatment strategies for changes in total cholesterol, triglycerides, waist circumference, and waist-to-hip ratio.	Coenrollment in the FIRST study	None
ADHERENCE: CPCRA 062	This sub-study of CPCRA 058 FIRST and 064 MDR evaluates the effectiveness of the presence of a medication manager who works individually with study participants, addressing the knowledge, motivation and skills necessary for adherence to HAART treatment versus no medication manager.	Coenrollment in the FIRST study	None
Long Term Monitoring: CPCRA 060	This study is designed to gather information to guide clinical decision-making regarding when to start treatment, which drugs constitute the optimal initial regimens, or when and how to adjust therapeutic regimens that do not provide adequate benefit.	Either antiretroviral-naïve, defined as no previous PI or NNRTI use, less than 1 week of 3TC treatment, and less than 4 weeks of NRTI treatments Or currently or previously enrolled in a qualifying CPCRA trial	None
Multi-drug Resistant Virus (MDR): CPCRA 064	This study is designed to determine whether a prescribed 4-month structured treatment interruption (STI) followed by initiation of a new antiretroviral regimen delays clinical disease progression as compared to immediately initiating a new antiretroviral regimen in patients with multi-drug resistant (MDR) virus. Viral load, GART and PART tests will be provided by the study sponsor.	Evidence of multi-drug resistant virus based on the results of a GART test Viral load greater than 10,000 copies Intention to initiate a new antiretroviral therapy	Vaccination within 14 days of screening Use of IL-2 within 120 days Active opportunistic infection Pregnancy or breastfeeding
Interleukin-2: ESPRIT 001 Check the website: www.espritstudy.org	This is an international randomized trial designed to compare the effects of subcutaneous recombinant interleukin-2 (SC rIL-2) versus no SC rIL-2 on disease progression over a 5-year follow-up period in patients takin combination antiretroviral therapy. SC rIL-2 will be provided by the study sponsor.	CD4+ cell count greater than 300 copies On or initiating combination antiretroviral therapy No evidence of active clinical disease for any AIDS-defining illness for at least one year	Prior use of rIL-2 Concurrent malignancy requiring cytotoxic chemotherapy Current use of certain medications History of autoimmune/inflammatory disease
CS-MM-9901 Interleukin-2 (L2-7001): Chiron	This is a dose-escalation study with two phases. Phase A will be an open-label dose escalation of recombinant human interleukin-2 (L2-7001). Phase B, in which we are participating, will involve randomization into 1.) one of three dose levels of L2-7001 plus antiretroviral therapy (ART), 2.) one of two dosing levels of Proleukin plus ART or 3.) ART alone. This phase is designed to assess the immunologic efficacy of the three different doses in combination with ART. All laboratory tests, L2-7001, and Proleukin will be provided by the study sponsor.	CD4+ cell count greater than 300 and less than 500 Viral load < 10,000 copies Stable ART containing a PI or NNRTI for at least 4 months	Prior therapy with IL-2 History of autoimmune disease Use of hydroxyurea within 4 months of study entry Active AIDS-defining illness
STARR:GlaxoWellcome ESS40011	This is a 24-week study comparing the licensed agernerase (APV) dose of 1200 mg BID to a lower APV dose of 600 mg BID in the presence of norvir (RTV 100 mg BID). APV, RTV and all laboratory tests will be provided by the study sponsor.	CD4+ cell count greater than 50 Antiretroviral naïve OR Naïve to APV with viral load greater than 1,000 and less than 10,000 copies	Clinical Diagnosis of AIDS within 30 days Pre-existing condition interfering with normal GI anatomy or motility or a malabsorption syndrome Acute or chronic hepatitis
Providence:NR15961 Peginterferon alfa-2a	This is a three-arm study designed to compare the safety and efficacy of peginterferon alfa-2a (PEG-IFN) monotherapy versus combination therapy of PEG-IFN with ribavirin versus combination therapy of interferon alfa-2a (IFN) with ribavirin in patients co-infected with hepatitis C virus and HIV. All study medication and laboratory evaluations will be provided by the sponsor.	Stable antiretroviral regimen for at least 6 weeks Chronic liver disease consistent with chronic hepatitis C infection§HCV-RNA viral load greater than 1000 copies CD4+ cell count greater than 200 OR greater than 100 with a viral load less than 5000 copies.	Prior use of IFN or ribavirin Positive test at screening for anti-HAV IgM Ab, HbsAg, anti-HBc IgM Ab, HBeAg

	*NOTE: There are additional criteria not included in this listing which may affect a person's ability to enroll in a protocol.
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		FREE • FREE • FREE • FREE Bioelectrical Impedance Analysis (BIA) Testing Available at the Research & Education Group Bioelectrical Impedance Analysis (BIA), a technology that detects changes in body composition, is now being offered at The Research & Education Group. The BIA is a simple, quick, and painless test which estimates muscle mass, body fat, and total body water by measuring tissue resistance and reactance following the application of a small electrical stimulus. The BIA procedure is safe, noninvasive, and fast. Because monitoring of body composition may be important to overall health and immune function, the BIA test is another tool in the clinical management and care of persons living with HIV disease. Interpretation of the test results and nutrition counseling are provided.
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