Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
|ClinicalTrials.gov Identifier: NCT00005017|
Recruitment Status : Unknown
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Lamivudine Drug: Stavudine||Phase 4|
Patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. Within each group they are stratified based on HIV-1 plasma RNA levels.
Group 1: Patients receive 3TC/ABC/d4T; Group 2: Patients receive 3TC/ABC/EFV; and Group 3: Patients receive 3TC/ABC/APV/RTV.
Treatment continues for 96 weeks. Blood samples are collected to measure plasma HIV RNA and CD4 counts and patients are assessed regularly. In the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Official Title:||A Phase IV, Open-Label, Randomized Study to Compare the Efficacy and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) for 96 Weeks in the Treatment of HIV-1 Infected Subjects Who Are Antiretroviral Therapy Naive|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005017
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|