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 - Full Text View

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.

Sponsored by:	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

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Lamivudine Indinavir Indinavir Sulfate Abacavir Abacavir sulfate Nelfinavir Nelfinavir Mesylate VX 478

U.S. FDA Resources

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

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

Study ID Numbers:	264M, PRO20005
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002423
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

Study placed in the following topic categories:

Virus Diseases

Amprenavir

Sexually Transmitted Diseases, Viral

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Nelfinavir

Abacavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Antibiotics, Antitubercular

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Bacterial Agents

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Antitubercular Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 07, 2008