Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
NCT ID: NCT00002241
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Ritonavir
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
* Are age 16 or older (consent of a parent or guardian required if under 18).
* Agree to practice abstinence or use barrier methods of birth control (such as condoms).
* Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)
Exclusion Criteria
* Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
* Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
* Have changed their medications in the last 2 weeks.
* Are allergic to IDV, RTV, d4T, or 3TC.
* Have used certain medications (see the technical summary for more detail).
* Are pregnant or breast-feeding.
16 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Apogee Med Group
San Diego, California, United States
Univ of California at San Francisco Gen Hosp
San Francisco, California, United States
HIV Institute / Davies Med Ctr
San Francisco, California, United States
Kaiser Foundation Hospital
San Francisco, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
CRI New England
Brookline, Massachusetts, United States
SUNY Health Sciences Ctr
Brooklyn, New York, United States
Chelsea Village Med Ctr
New York, New York, United States
Liberty Med Group
New York, New York, United States
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Montefiore Med Ctr
The Bronx, New York, United States
Mark Watkins
Philadelphia, Pennsylvania, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, United States
Countries
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Other Identifiers
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094-00
Identifier Type: -
Identifier Source: secondary_id
CRX463
Identifier Type: -
Identifier Source: secondary_id
246T
Identifier Type: -
Identifier Source: org_study_id