A Study of a Combination of Four Drugs in Patients With Recent HIV Infection
The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.
Drug: Indinavir sulfate
Drug: Abacavir sulfate
|Study Design:||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, 48-Week, Uncontrolled, Open-Label Study Designed to Evaluate the Safety and Efficacy of Quadruple Antiretroviral Therapy (EPIVIR, Abacavir, Amprenavir, and Indinavir) in Subjects Acutely Infected With HIV-1|
Patients receive a four-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (3TC and abacavir) and two protease inhibitors (amprenavir and indinavir) for a minimum of 48 weeks. At specified time points, patients undergo physical assessments and efficacy evaluations which include plasma HIV-1 RNA measurements and CD4 cell counts. Depending on the immunologic and virologic status of the patient, further testing may be done to determine whether quadruple drug therapy can attain undetectable viral levels.
|United States, New York|
|Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ|
|New York, New York, United States, 10021|
|United States, Rhode Island|
|Miriam Hosp / Family Healthcare Ctr at SSTAR|
|Providence, Rhode Island, United States, 02906|