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Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Ritonavir
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry. Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry. Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly). Experienced treatment failure within 24 weeks of study entry. Are 18 years of age or older. Agree to use effective barrier methods of birth control (such as condoms) during the study. Exclusion Criteria You will not be eligible for this study if you: Are allergic to ritonavir or indinavir. Have hepatitis. Have an abnormal chest x-ray or abnormal liver function tests. Have taken 2 protease inhibitors at the same time for 7 or more days. Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry. Have a medical condition that might make it unsafe for you to take the study drugs. Have experienced resistance to NRTIs and no new NRTI therapy is possible. Have taken certain medications. Abuse alcohol or drugs. Are pregnant or breast-feeding.

Sites / Locations

  • LAC / USC Med Ctr / Infectious Diseases
  • Univ of Miami School of Medicine
  • Northwestern Univ / Div of Infect Diseases
  • Chase Braxton Health Service
  • Beth Israel Deaconess Med Ctr
  • Albany Med College
  • Univ of North Carolina / Infectious Disease Division
  • The Research and Education Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002361
Brief Title
Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors
Official Title
A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 200 Mg b.i.d. and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
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 and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.
Detailed Description
Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.

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, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Ritonavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry. Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry. Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly). Experienced treatment failure within 24 weeks of study entry. Are 18 years of age or older. Agree to use effective barrier methods of birth control (such as condoms) during the study. Exclusion Criteria You will not be eligible for this study if you: Are allergic to ritonavir or indinavir. Have hepatitis. Have an abnormal chest x-ray or abnormal liver function tests. Have taken 2 protease inhibitors at the same time for 7 or more days. Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry. Have a medical condition that might make it unsafe for you to take the study drugs. Have experienced resistance to NRTIs and no new NRTI therapy is possible. Have taken certain medications. Abuse alcohol or drugs. Are pregnant or breast-feeding.
Facility Information:
Facility Name
LAC / USC Med Ctr / Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern Univ / Div of Infect Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Chase Braxton Health Service
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Albany Med College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Univ of North Carolina / Infectious Disease Division
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

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Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors

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