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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002423
• Other study ID #: 264M
• Secondary ID: PRO20005
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: March 1999

Study information

• Verified date: December 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Abacavir sulfate

• Amprenavir

• Nelfinavir mesylate

• Lamivudine

Locations

Country	Name	City	State
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	Natl Institute of Allergy and Infectious Diseases	Bethesda	Maryland
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Bentley-Salick Med Practice	New York	New York
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Saint Francis Mem Hosp	San Francisco	California
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,