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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborators: Bristol-Myers Squibb; Dupont Applied Biosciences; Glaxo Wellcome
• Treatments: Adefovir; Adefovir dipivoxil; Didanosine; Efavirenz; Lamivudine

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.