Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, effectiveness, and tolerability of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV infected people in Wenxi County, Shanxi Province, China.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Zidovudine

Criteria

Inclusion Criteria:

• HIV infected

• Antiretroviral naive

• CD4 count of less than 350 cells/mm3 within 30 days of study entry

• Willing to use acceptable forms of contraception

• Willing to stay in the study area for the duration of the study

• Willing to not consume traditional Chinese medicines for the duration of the study

• Willing to adhere to the follow-up study schedule

Exclusion Criteria:

• Presence of an acute serious medical illness within 14 days prior to study entry. Participants with recently diagnosed opportunistic infections (except tuberculosis [TB]) and are stable on therapy for more than 30 days are eligible.

• Current pancreatitis

• Require certain medications

• Pregnant or breastfeeding