A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002423

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: December 1999

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

Official Title ^ICMJE

A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks

Brief Summary

This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.

Detailed Description

Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Indinavir sulfate
Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Nelfinavir mesylate
Drug: Lamivudine

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria

You may be eligible for this trial if you:

Are HIV-positive.
Are 13 years of age or older.
Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
Have the written consent of a parent or legal guardian if you are under age 18.
Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
Are willing to complete the 48-week study.

Exclusion Criteria

You will not be eligible for this trial if you:

Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
Have had certain types of hepatitis in the past 6 months.
Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.

Sex/Gender

Sexes Eligible for Study:

All

Ages

13 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00002423

Other Study ID Numbers ^ICMJE

264M
PRO20005

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Glaxo Wellcome

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

NIH AIDS Clinical Trials Information Service

Verification Date

December 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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