Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China
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
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started May 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2005
CompletedFirst Posted
Study publicly available on registry
January 4, 2005
CompletedStudy Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 23, 2011
February 1, 2011
2 years
January 3, 2005
February 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 15262561BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yunzhen Cao, MD
The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 3, 2005
First Posted
January 4, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 23, 2011
Record last verified: 2011-02