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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Efavirenz
Lamivudine/zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    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

    Full Information

    First Posted
    January 3, 2005
    Last Updated
    February 22, 2011
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00100594
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Treatment Naive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Efavirenz
    Intervention Type
    Drug
    Intervention Name(s)
    Lamivudine/zidovudine
    Primary Outcome Measure Information:
    Title
    Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
    Title
    treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines
    Secondary Outcome Measure Information:
    Title
    Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
    Title
    adherence, defined by continuous and dichotomous measure
    Title
    ARV drug resistance

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yunzhen Cao, MD
    Organizational Affiliation
    The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15262561
    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.
    Results Reference
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    Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected People in Wenxi County, Shanxi Province, China

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