Search / Trial NCT00000914

A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Drug Therapy, Combination Hiv Protease Inhibitors Ritonavir Indinavir Saquinavir Reverse Transcriptase Inhibitors Viral Load Nelfinavir

Description

Current recommendations for the initial treatment of HIV infection have centered on the reduction of plasma HIV levels. It has been shown that a combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs) and a PI is the most effective barriers to disease progression. This study attempts to demonstrate these data. Two options are available for patients whose initial PI-containing regimen has failed to suppress viral replication. Option 1 consists of immediate versus deferred use of a nonnucleoside reverse transcriptase inhibitor (NNRTI). Patients who choose Option 1 are randomize...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Have an HIV RNA count of at least 400 copies/ml.
  • Are at least 13 years old (need consent if under 18).
  • Have been on antiretroviral treatment (including at least 2 NRTIs) for at least 16 weeks prior to study entry.
  • Agree to practice abstinence or to use effective methods of birth control, including a barrier method, during the study.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Are pregnant or breast-feeding.
  • Have active opportunistic (HIV-associated) infections.
  • Have taken nelfinavir (NFV) for more than 2 weeks after failing indinavir/ritonavir (IDV/RTV) treatment or have taken IDV/RTV for more than 2 weeks after failing NFV treatment.
  • Have used any protease inhibitor other than NFV or IDV/RTV for more than 2 weeks.
  • Have used any non-nucleoside reverse transcriptase inhibitor (NNRTI) for more than 1 week.

Attachments

readout_NCT00000914_2024-03-02.pdf

4.5 MB

NCT00000914_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

Denver, Colorado, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

Philadelphia, Pennsylvania, United States

Washington, District Of Columbia, United States

Portland, Oregon, United States

Albuquerque, New Mexico, United States

Detroit, Michigan, United States

New York, New York, United States

Richmond, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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