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A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT00082394•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (45)

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Fort Collins, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Myers, Florida, United States

Key Dates

Start Date

April 26, 2004

Primary Completion Date

March 1, 2006

Completion Date

March 1, 2006

Last Updated

May 24, 2017

Conditions

Infection, Human Immunodeficiency Virus IHIV Infection

Interventions

Trizivir

DRUG

atazanavir

DRUG

Combivir

DRUG

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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