Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

This study has been completed.

First Received on August 30, 2001. Last Updated on June 23, 2005 History of Changes

Sponsor:	Gilead Sciences
Collaborators:	Bristol-Myers Squibb Glaxo Wellcome Dupont Applied Biosciences
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002234

Purpose

The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

Condition	Intervention	Phase
HIV Infections	Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Phase II, 48 Week, Open-Label Study Designed to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Simplified Dosing Regimen of Preveon (Adefovir Dipivoxil; bis-POM PMEA), Videx (Didanosine; ddI), Sustiva (Efavirenz; DMP-266), and Epivir (Lamivudine; 3TC) Administered Once Daily for the Treatment of HIV-1 Infection

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Didanosine Adefovir Lamivudine Adefovir dipivoxil Efavirenz

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:

Detailed Description:

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.

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.
Are at least 13 years old (need consent of parent or guardian if under 18).
Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
Have a CD4+ count of 50 cells/mm3 or more.

Exclusion Criteria

You will not be eligible for this study if you:

Are diagnosed with hepatitis within 30 days prior to study entry.
Have certain serious medical conditions, including an AIDS-defining clinical condition.
Received chemotherapy or radiation therapy within 30 days of study entry.
Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
Have ever taken 3TC.
Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Have taken medications that affect your immune system within 30 days prior to study entry.
Have received a vaccine within 30 days prior to study entry.
Are enrolled in another anti-HIV drug study while participating in this study.
Abuse alcohol or drugs.
Are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002234

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

Bristol-Myers Squibb

Glaxo Wellcome

Dupont Applied Biosciences

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002234 History of Changes
Other Study ID Numbers:	232J, ICC 604
Study First Received:	August 30, 2001
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Drug Therapy, Combination
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
Didanosine
Adefovir dipivoxil
Adefovir

Lamivudine
Reverse Transcriptase Inhibitors
Efavirenz
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 12, 2012