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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002423

Purpose

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	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Drug: Lamivudine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Lamivudine Abacavir Indinavir Indinavir Sulfate Nelfinavir Nelfinavir Mesylate VX 478 Abacavir sulfate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	100
Study Start Date:	March 1999

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002423

Locations

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

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

Study ID Numbers:	264M, PRO20005
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002423 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir
Nelfinavir

VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Indinavir
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Nelfinavir

Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on November 25, 2009