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NCT00100594 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00100594
Other study ID # CIPRA CH 004
Secondary ID
Status Completed
Phase N/A
First received January 3, 2005
Last updated February 22, 2011
Start date May 2005
Est. completion date May 2007

Study information
Verified date February 2011
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Efavirenz

• Lamivudine/zidovudine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

References & 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
Primary treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines
Secondary Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
Secondary adherence, defined by continuous and dichotomous measure
Secondary ARV drug resistance
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