Trial | NCT00100568  Report issue

Title

Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal
A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    44
The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal.
Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.

This study will last 96 weeks. At study entry, all participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits during the study; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires. An off-study visit will occur at approximately one month after Week 96, with assessments and procedures similar to visits during the study.
Study Started
Jul 31
2006
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Sep 06
2013
Estimate

Drug Efavirenz

600 mg tablet taken orally daily

  • Other names: EFV

Drug Lamivudine/zidovudine

150mg lamivudine/300mg zidovudine tablet taken orally twice daily

  • Other names: 3TC/ZDV

1 Experimental

All participants will be given an ARV regimen of lamivudine/zidovudine and efavirenz at study entry. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens.

Criteria 

Inclusion Criteria:

HIV-infected
Have never taken ARV drugs
CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
Willing to stay in the study area for the duration of the study
Willing to use acceptable forms of contraception

Exclusion Criteria:

HIV-2 infected
Systemic chemotherapy (except interferon) within 6 months prior to study entry
Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
Have taken certain medications within 30 days of study entry
Pregnancy or breastfeeding
No Results Posted