Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz

March 3, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz

This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen).

HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. This was originally a multi-center study, but it has been closed at all other sites. It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. Safety and viral load data continue to be collected.

Study Type

Interventional

Enrollment

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Allergy and Infectious Diseases (NIAID)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION/EXCLUSION CRITERIA:

Subjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. There has been and will be no other new enrollment. Thus, subjects who were not previously enrolled are excluded.

Subjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980031
  • 98-I-0031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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