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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002234
• Other study ID #: 232J
• Secondary ID: ICC 604
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2001
• Last updated: June 23, 2005

Study information

• Verified date: November 2004
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Adefovir dipivoxil

• Lamivudine

• Didanosine

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Univ of Colorado / Health Science Ctr	Denver	Colorado
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Brown Univ School of Medicine	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Gilead Sciences	Bristol-Myers Squibb, Dupont Applied Biosciences, Glaxo Wellcome

Country where clinical trial is conducted

United States,