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

June 23, 2005 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • LAC / USC Med Ctr / Infectious Diseases
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ / Div of Infect Diseases
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Chase Braxton Health Service
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ of North Carolina / Infectious Disease Division
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 246S
  • 088-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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