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A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00002442
Lead Sponsor
Glaxo Wellcome
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (12)

AIDS Healthcare Foundation

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Palo Alto Veterans Affairs Health Care System

πŸ‡ΊπŸ‡Έ

Palo Alto, California, United States

Dupont Circle Physicians Group

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

IDC Research Initiative

πŸ‡ΊπŸ‡Έ

Altamonte Springs, Florida, United States

North Broward Hosp District

πŸ‡ΊπŸ‡Έ

Fort Lauderdale, Florida, United States

Steinhart Medical Associates

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

Northwestern Univ Med School

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

Saint Vincents Hosp

πŸ‡ΊπŸ‡Έ

New York, New York, United States

St Lukes - Roosevelt Hosp Ctr

πŸ‡ΊπŸ‡Έ

New York, New York, United States

MCP Hahnemann Univ Hosp

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

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AIDS Healthcare Foundation
πŸ‡ΊπŸ‡ΈLos Angeles, California, United States

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