Trials
Search / Trial NCT00001133

Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of January 15, 2025

Completed

Keywords

Dose Response Relationship, Drug Drug Therapy, Combination Hiv Protease Inhibitors Ritonavir Indinavir Anti Hiv Agents Pharmacokinetics Treatment Experienced

ClinConnect Summary

IDV, a protease inhibitor, has shown excellent clinical and virologic responses when combined with 2 nucleoside analogues. Although effective, the pharmacokinetics of IDV make it difficult to use in many patients. The drug has a short half-life and requires administration in high doses every 8 hours with significant dietary restrictions. Research has shown that IDV kinetics can be improved significantly by the addition of RTV, allowing for administration of IDV at lower doses every 12 hours. The half-life of IDV is prolonged 3- to 5-fold when administered with RTV. Based on these results, i...

Gender

ALL

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 (level of HIV in the blood) of at least 500 copies/ml but no more than 100,000 copies/ml within 45 days of study entry.
  • Have been taking the following anti-HIV drug combination for at least 12 weeks before study entry: 2 NRTIs plus amprenavir (APV), nelfinavir (NFV), saquinavir (SQV), or NFV plus SQV.
  • Are naive to at least 1 NRTI. This means that there is at least 1 NRTI that the patient has not taken for more than 14 days. In the case of lamivudine (3TC), naive means that the patient has never taken this drug.
  • Are willing and able to drink 1.5 liters (a little over 1.5 quarts) of water or other fluids a day.
  • Agree to use an effective barrier method of birth control (such as condoms) during the study and for 3 months after.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have taken protease inhibitors other than APV, NFV, SQV, or NFV plus SQV.
  • Are resistant to the effects of IDV or RTV, as shown by a blood test. (Patients whose viral load is between 500 and 1,000 copies/ml will not need to be tested.)
  • Have any active opportunistic (AIDS-related) infection in the 14 days before study entry.
  • Have any medical condition or history of disease that would prevent them from completing the study or put them at risk.
  • Have cancer that requires chemotherapy.
  • Have an active infection that requires treatment in the 14 days before study entry.
  • Have a fever for a week or more in the 30 days before study entry.
  • Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) in the 30 days before study entry.
  • Have received a vaccine in the 21 days before study entry.
  • Have received an experimental drug or a drug that affects the immune system in the 30 days before study entry.
  • Have taken or plan to take certain other medications that may affect the study.
  • Are pregnant or breast-feeding.

Trial Officials

John G. Gerber

Study Chair

Edward P. Acosta

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Birmingham, Alabama, United States

Baltimore, Maryland, United States

New York, New York, United States

Los Angeles, California, United States

San Francisco, California, United States

Pittsburgh, Pennsylvania, United States

Cincinnati, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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