Search / Trial NCT00000912

A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

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

Placebos Drug Therapy, Combination Hiv Protease Inhibitors Vx 478 Anti Hiv Agents Viral Load Efavirenz

Description

A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation (I50V); and 3) its cross-resistance profile to the approve...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for this study if they:
  • Are HIV-positive.
  • Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs.
  • Are over 13 years of age (consent of parent or guardian required if under 18).
  • Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after.
  • Exclusion Criteria
  • Patients will not be eligible for this study if they:
  • Have hepatitis within 90 days prior to study entry.
  • Have a history of a peripheral neuropathy within 60 days of study entry.
  • Have an unexplained temperature for a 7-day period.
  • Have chronic diarrhea within 30 days prior to study entry.
  • Have cancer requiring chemotherapy.
  • Received any therapy for infection or other illness within 30 days prior to study entry.
  • Have received certain other medications.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00000912_2024-05-23.pdf

4.5 MB

NCT00000912_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

Los Angeles, California, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, 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

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Baltimore, Maryland, United States

Buffalo, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

Los Angeles, California, United States

San Francisco, California, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Hershey, Pennsylvania, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Menlo Park, California, United States

New York, New York, United States

Pittsburgh, Pennsylvania, United States

Los Angeles, California, United States

Tripler Amc, Hawaii, 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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