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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Efavirenz
* Drug: Lamivudine/zidovudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Efavirenz|nan|
|Drug: Lamivudine/zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality |  |  | 
| treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks |  |  | 
| adherence, defined by continuous and dichotomous measure |  |  | 
| ARV drug resistance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Naive