Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Ritonavir
Lamivudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Eligibility 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.
Sites / Locations
- Univ of Miami School of Medicine
- Albany Med College
- SUNY at Stony Brook / Division of Infectious Diseases
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002451
First Posted
January 17, 2000
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00002451
Brief Title
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
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 Type
Interventional
2. Study Status
Record Verification Date
July 2002
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
SUNY at Stony Brook / Division of Infectious Diseases
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
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