Search / Trial NCT00000918

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Drug Therapy, Combination Hiv Protease Inhibitors Reverse Transcriptase Inhibitors Salvage Therapy Anti Hiv Agents Viral Load

Description

To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir. Patients are randomly selected...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are over 13 years old (need consent of parent or guardian if under 18).
  • Are HIV-positive.
  • Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).
  • Agree to abstinence or use of effective birth control during the study.
  • Have been taking NFV for the past 12 weeks.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have a fever for 7 days or diarrhea for 30 days before study entry.
  • Have a history of peripheral neuropathy within 60 days of study entry.
  • Have hepatitis.
  • Have any malignancy (cancer) other than minimal Kaposi's sarcoma.
  • Are pregnant or breast-feeding.
  • Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.
  • Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.
  • Have received an HIV vaccine 30 days before study entry.
  • Are receiving certain other medications.

Attachments

readout_NCT00000918_2024-05-23.pdf

4.5 MB

NCT00000918_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

Birmingham, Alabama, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Chicago, Illinois, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Boston, Massachusetts, United States

Buffalo, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Menlo Park, California, United States

San Rafael, California, United States

New York, New York, 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

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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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