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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Phase 3
Completed
Conditions
HIV Infections
Registration Number
NCT00002371
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.

Detailed Description

Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

Harbor UCLA Med Ctr

🇺🇸

Torrance, California, United States

Univ of South Florida

🇺🇸

Tampa, Florida, United States

SUNY at Stony Brook / Division of Infectious Diseases

🇺🇸

Stony Brook, New York, United States

Houston Clinical Research Network / Div of Montrose Clinic

🇺🇸

Houston, Texas, United States

Univ of Utah / School of Medicine / Div of Infect Dis

🇺🇸

Salt Lake City, Utah, United States

Sunnybrook Health Science Ctr

🇨🇦

North York, Ontario, Canada

Montreal Gen Hosp / Div of Clin Immuno and Allergy

🇨🇦

Montreal, Quebec, Canada

Univ of Puerto Rico School of Medicine

🇵🇷

San Juan, Puerto Rico

Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States

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