Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
3 other identifiers
interventional
80
1 country
18
Brief Summary
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 2001
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- 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.)
You may not qualify if:
- Patients will not be eligible for this study if they:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Apogee Med Group
San Diego, California, 92101, United States
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110, United States
HIV Institute / Davies Med Ctr
San Francisco, California, 94114, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
CRI New England
Brookline, Massachusetts, 02146, United States
SUNY Health Sciences Ctr
Brooklyn, New York, 11203, United States
Chelsea Village Med Ctr
New York, New York, 10014, United States
Liberty Med Group
New York, New York, 10016, United States
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456, United States
Montefiore Med Ctr
The Bronx, New York, 10467, United States
Mark Watkins
Philadelphia, Pennsylvania, 19107, United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2001-07