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

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002423

Collaborator

(none)

100

Enrollment

Locations

12.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Lamivudine	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Francis Mem Hosp	San Francisco	California	United States	94109
2	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
3	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
4	Natl Institute of Allergy and Infectious Diseases	Bethesda	Maryland	United States	20892
5	Kansas City AIDS Research Consortium	Kansas City	Missouri	United States	64111
6	Bentley-Salick Med Practice	New York	New York	United States	10011
7	Associates in Med and Mental Health	Tulsa	Oklahoma	United States	74114
8	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	972109951