A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

Study Overview
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Brief Summary
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The aim of this study was to assess whether TRIZIVIR, administered twice-daily was as safe, tolerable and efficacious as a combination of the drugs COMBIVIR administered twice-daily and atazanavir administered once daily. Over the course of 48 weeks, various parameters that measure safety, tolerability and efficacy of the investigational drugs were measured and compared.

Detailed Description
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A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (abacavir 300mg, lamivudine 150mg, and zidovudine 300mg) BID vs Combivir (lamivudine 150mg and zidovudine 300mg) BID plus atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects over 48 Weeks

Official Title
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A Phase IV Randomized, Multicenter, Open-Label Study to Compare the Safety, Tolerability and Efficacy of Trizivir (Abacavir 300mg, Lamivudine 150mg, and Zidovudine 300mg) BID vs Combivir (Lamivudine 150mg and Zidovudine 300mg) BID Plus Atazanavir 400mg QD in Antiretroviral Naive HIV-1 Infected Subjects Over 48 Weeks

Conditions
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Infection, Human Immunodeficiency Virus I, HIV Infection

Intervention / Treatment
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* Drug: Trizivir
* Drug: atazanavir
* Drug: Combivir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adults with documented HIV-1 infection. Past use of HIV drugs must have been less than 15 days. Plasma HIV-1 RNA between 500 and 20,000 copies/mL. CD4+ cell count greater than 100 cells/mm3. Willing/able to provide written informed consent. Exclusion criteria: Have AIDS at screening. Pregnant or breastfeeding. Underlying medical conditions considered to be significant for this protocol. Participating in other investigational drug trials. In the opinion of the investigator, would be unable to complete 48 weeks of dosing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trizivir|nan|
|Drug: atazanavir|nan|
|Drug: Combivir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint was drug efficacy, measured as the proportion of study subjects who had plasma HIV-1 RNA less than 50 copies/mL at week 48 and did not meet the definition of virologic failure through this timepoint. |  | 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % patients with plasma HIV-1 RNA <50 and <400 copies/mL at weeks 24 & 48; Change from BL in plasma HIV-1 RNA and CD4+ measures; AEs; Time to virologic failure |  | 48 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, drug efficacy, TRIZIVIR, tolerability, COMBIVIR, HIV, atazanavir