Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

This study has been completed.

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

Sponsor:	Gilead Sciences
Collaborators:	Glaxo Wellcome Dupont Applied Biosciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002419

Purpose

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).

Condition	Intervention	Phase
HIV Infections	Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Drug: Adefovir dipivoxil	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of Novel Quadruple-Combination Therapy With Preveon (Adefovir Dipivoxil; Bis-POM PMEA), Abacavir (1592U89), Sustiva (Efavirenz; DMP-266), and Amprenavir (141W94) for the Treatment of HIV-1 Infection in Patients Who Have Failed Previous Protease Inhibitor Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Adefovir Abacavir Adefovir dipivoxil Efavirenz VX 478 Abacavir succinate Abacavir sulfate

U.S. FDA Resources

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

Estimated Enrollment:

Detailed Description:

Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.

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 study if you:

Are HIV-positive.
Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
Are at least 13 years old (need consent of parent or guardian if under 18).
Are able to complete the study.
Agree to use effective barrier methods of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
Are participating in another anti-HIV drug trial during this study.
Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
Have been diagnosed with hepatitis within the past 30 days.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.
Have ever taken NNRTIs.
Have ever taken ddI or d4T.
Have received chemotherapy or radiation therapy within 30 days prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002419

Locations

United States, California
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
United States, Colorado
Univ of Colorado / Health Science Ctr
Denver, Colorado, United States, 80262
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Rhode Island
Brown Univ School of Medicine
Providence, Rhode Island, United States, 02908
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666

Sponsors and Collaborators

Gilead Sciences

Glaxo Wellcome

Dupont Applied Biosciences

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002419 History of Changes
Other Study ID Numbers:	299A, ICC 605
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Amprenavir
Adefovir dipivoxil
Adefovir

Efavirenz
Abacavir
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents
Anti-HIV Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012