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Clinical Trials/NCT00004852
NCT00004852
Completed
Phase 2

A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

Glaxo Wellcome62 sites in 4 countriesSeptember 1999
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ConditionsHIV Infections
DrugsEfavirenzLamivudineZidovudine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Glaxo Wellcome
Locations
62
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Detailed Description

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Registry
clinicaltrials.gov
Start Date
September 1999
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Glaxo Wellcome

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (62)

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