Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
|ClinicalTrials.gov Identifier: NCT00011895|
Recruitment Status : Unknown
Verified March 2002 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: Abacavir sulfate, Lamivudine and Zidovudine Drug: Efavirenz||Phase 4|
Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.
An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Official Title:||A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects|
|Study Start Date :||February 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011895
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