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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002234

Run by

Gilead Sciences

People needed

25

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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