Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 Co...

Detailed Description

HIV infection in China has reached epidemic proportions, especially in poor rural communities. Among the infected are former commercial plasma donors who became infected through contaminated blood col...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00100594

Start Date

May 1 2005

End Date

May 1 2007

Last Update

February 23 2011

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