Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Ritonavir (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 2
Status: No longer recruiting
Sponsored by: Merck
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.
Clinical Details
Official title:
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
Study design: Interventional, Treatment, Safety Study
Detailed description:
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
Eligibility
Minimum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.)
Exclusion Criteria
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.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of California at San Francisco Gen Hosp, San Francisco, California 94110, United States
Kaiser Foundation Hospital, San Francisco, California 94118, United States
HIV Institute / Davies Med Ctr, San Francisco, California 94114, United States
Apogee Med Group, San Diego, California 92101, 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
Mount Sinai Med Ctr, New York, New York 10029, United States
Montefiore Med Ctr, Bronx, New York 10467, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10456, 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
SUNY Health Sciences Ctr, Brooklyn, New York 11203, United States
Mark Watkins, Philadelphia, Pennsylvania 19107, United States
Univ of Texas / Thomas Street Clinic, Houston, Texas 77030, United States
Additional Information
Last updated: June 23, 2005
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