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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002361
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2000
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Ritonavir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002361

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002361     History of Changes
Other Study ID Numbers: 246S, 088-00
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Indinavir
Ritonavir
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014