Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00100594

First received: January 3, 2005
Last updated: February 22, 2011
Last Verified: February 2011
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Drug : Efavirenz
Drug : Lamivudine/zidovudine

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Enrollment: 100
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100594

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: Yunzhen Cao, MD The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00100594   History of Changes  
Other Study ID Numbers: CIPRA CH 004  
Study First Received: January 3, 2005  
Last Updated: February 22, 2011  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lamivudine
Efavirenz
Zidovudine
Lamivudine, zidovudine drug combination

ClinicalTrials.gov processed this data on March 27, 2020
This information is provided by ClinicalTrials.gov.