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:

Collaborators:

Bristol-Myers Squibb

Glaxo Wellcome

Dupont Applied Biosciences

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00002234

First received: August 30, 2001

Last updated: June 23, 2005

Last verified: November 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	August 30, 2001
Last Updated Date	June 23, 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	Complete list of historical versions of study NCT00002234 on ClinicalTrials.gov Archive Site
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	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Efavirenz Drug: Adefovir dipivoxil Drug: Lamivudine Drug: Didanosine
Study Arm (s)	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	25
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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002234
Other Study ID Numbers ^ICMJE	232J, ICC 604
Has Data Monitoring Committee	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
Information Provided By	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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