Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
Sponsored by: Merck
Summary
The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV)
in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have
never received anti-HIV therapy. This study will look at the effectiveness of this drug
combination and side effects.
Clinical Details
Official title: A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients
Study design: Treatment, Dose Comparison, Safety Study
Detailed description:
Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive
daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12,
16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor
CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV
pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of
adverse events leading to study discontinuation is tabulated.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of 5,000 copies/ml or greater.
- Have a CD4 count of at least 50 cells/mm3.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have taken any antiretroviral (anti-HIV) agent.
- Are pregnant.
Locations and Contacts
Univ of Miami School of Medicine, Miami, Florida 33136, United States
Albany Med College, Albany, New York 12208, United States
SUNY at Stony Brook / Division of Infectious Diseases, Stony Brook, New York 11794, United States
Additional Information
Last updated: June 23, 2005
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