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

This study is not yet open for patient recruitment.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition Treatment or Intervention
HIV Infections
 Drug: Efavirenz
 Drug: Lamivudine/zidovudine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: A Feasibility Study of Lamivudine/Zidovudine (3TC/ZDV) Plus Efavirenz (EFV) as Initial Therapy of HIV-1 Infected Patients in a Rural Area of China

Further Study Details: 
Primary Outcomes: Cumulative treatment failure at 52 weeks; treatment-limiting toxicity
Expected Total Enrollment:  100

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 collection equipment. This study will evaluate the safety, efficacy, and tolerability of an antiretroviral (ARV) regimen given to treatment-naive HIV infected adults. Participants will be recruited in Wenxi County, Shanxi Province.

This study will last 1 year. At study entry, all study participants will be given an ARV regimen consisting of lamivudine/zidovudine twice daily and efavirenz once daily. There will be 11 study visits; a physical exam, blood collection, and vital signs measurement will occur at all study visits. Participants will also receive safe sex and adherence counseling at all visits. Participants will be asked to complete an adherence questionnaire and will have their pills counted at most visits.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Exclusion Criteria:

  • Presence of newly diagnosed AIDS-defining opportunistic infection (OI) or condition requiring acute therapy at study entry. Patients with recently diagnosed OIs (except tuberculosis) who are stable on therapy for more than 30 days are not excluded.
  • Current pancreatitis
  • Require certain medications
  • Pregnant or breastfeeding

Location Information

Study chairs or principal investigators

Yunzhen Cao, MD,  Study Chair,  The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College   

More Information

Click here for more information on efavirenz

Click here for more information on lamivudine/zidovudine

Haga clic aquí para ver información sobre este ensayo clínico en español.

Publications

Wu Z, Rou K, Cui H. The HIV/AIDS epidemic in China: history, current strategies and future challenges. AIDS Educ Prev. 2004 Jun;16(3 Suppl A):7-17. Review.

Study ID Numbers:  CIPRA CH 004
Record last reviewed:  December 2004
Last Updated:  April 1, 2005
Record first received:  January 3, 2005
ClinicalTrials.gov Identifier:  NCT00100594
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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