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

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	June 24, 2005
Study 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; (submitted: June 23, 2005)	100
Original Enrollment ICMJE	Same as current
Study 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	No
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