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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100594
Recruitment Status : Completed
First Posted : January 4, 2005
Last Update Posted : February 23, 2011
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Efavirenz Drug: Lamivudine/zidovudine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Cumulative treatment failure at 52 weeks, defined by virologic failure or all-cause mortality
  2. treatment-limiting toxicity, defined by any participant in whom treatment is permanently discontinued according to toxicity guidelines

Secondary Outcome Measures :
  1. Tolerability, defined by premature discontinuation or failure to take ARV regimen for more than 8 consecutive weeks
  2. adherence, defined by continuous and dichotomous measure
  3. ARV drug resistance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100594

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Yunzhen Cao, MD The AIDS Research Center, Chinese Academy of Medical Sciences, Peking Union Medical College

Publications: Identifier: NCT00100594     History of Changes
Other Study ID Numbers: CIPRA CH 004
First Posted: January 4, 2005    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers