Clinical trial NCT00100594: Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Naive
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 County, Shanxi Province, China.

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 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 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

Primary outcomes:
measure: Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
measure: treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines
Secondary outcomes:
measure: Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
measure: adherence, defined by continuous and dichotomous measure
measure: ARV drug resistance
Other outcomes:
Locations:
Study officials:
affiliation: The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
name: Yunzhen Cao, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1521/aeap.16.3.5.7.35521.