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

NCT ID: NCT00002234

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Efavirenz

Intervention Type: DRUG

Adefovir dipivoxil

Intervention Type: DRUG

Lamivudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Glaxo Wellcome

INDUSTRY

Sponsor Role: collaborator

Dupont Applied Biosciences

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Locations

Pacific Oaks Med Group

Beverly Hills, California, United States

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Brown Univ School of Medicine

Providence, Rhode Island, United States

Hampton Roads Med Specialists

Hampton, Virginia, United States

Countries

United States

Other Identifiers

ICC 604

Identifier Type: -

Identifier Source: secondary_id

232J

Identifier Type: -

Identifier Source: org_study_id