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.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00002234

First Posted: August 31, 2001

Last Update Posted: June 24, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Bristol-Myers Squibb

Glaxo Wellcome

Dupont Applied Biosciences

Information provided by:

Bristol-Myers Squibb

Tracking Information

First Submitted Date ^ICMJE

August 30, 2001

First Posted Date ^ICMJE

August 31, 2001

Last Update Posted Date

June 24, 2005

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Efavirenz
Drug: Adefovir dipivoxil
Drug: Lamivudine
Drug: Didanosine

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

13 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00002234

Other Study ID Numbers ^ICMJE

232J
ICC 604

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gilead Sciences

Collaborators ^ICMJE

Bristol-Myers Squibb
Glaxo Wellcome
Dupont Applied Biosciences

Investigators ^ICMJE

Not Provided

PRS Account

Bristol-Myers Squibb

Verification Date

November 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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