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Clinical Trials/NCT00002442
NCT00002442
Completed
Phase 2

A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection

Glaxo Wellcome12 sites in 1 countryJune 1999
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ConditionsHIV Infections
DrugsIndinavir sulfateNelfinavir mesylateLamivudineStavudine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Glaxo Wellcome
Locations
12
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

Detailed Description

Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Registry
clinicaltrials.gov
Start Date
June 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 (12)

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