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A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

Not Applicable
Completed
Conditions
HIV Infections
Registration Number
NCT00002430
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Detailed Description

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
220
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 (46)

Univ of Alabama School of Med

🇺🇸

Montgomery, Alabama, United States

Ocean View Internal Medicine

🇺🇸

Long Beach, California, United States

AIDS Healthcare Foundation

🇺🇸

Los Angeles, California, United States

Tower ID Med Associates

🇺🇸

Los Angeles, California, United States

Oasis Clinic / King Drew Med Ctr

🇺🇸

Los Angeles, California, United States

Robert Scott MD

🇺🇸

Oakland, California, United States

AIDS Community Research Consortium

🇺🇸

Redwood City, California, United States

Saint Francis Mem Hosp / HIV Care Unit

🇺🇸

San Francisco, California, United States

Pacific Horizons Med Group

🇺🇸

San Francisco, California, United States

Kaiser Foundation Hospital

🇺🇸

San Francisco, California, United States

Scroll for more (36 remaining)
Univ of Alabama School of Med
🇺🇸Montgomery, Alabama, United States

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