Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal

This study has been completed.
Sponsor:
Collaborator:
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00100568
First received: January 3, 2005
Last updated: September 4, 2013
Last verified: September 2013

January 3, 2005
September 4, 2013
July 2006
June 2009   (final data collection date for primary outcome measure)
  • Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml [ Time Frame: Through Week 24 ] [ Designated as safety issue: No ]
  • Treatment-related toxicity of Grade 3 or higher as measured by development of drug-related toxicities severe enough to warrant dose modification, interruption, or permanent discontinuation [ Time Frame: Through Week 24 ] [ Designated as safety issue: Yes ]
  • Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml measured by Week 24 and confirmed by repeat testing within 30 days
  • treatment-related toxicity of Grade 3 or higher at any times during the first 24 weeks of treatment
Complete list of historical versions of study NCT00100568 on ClinicalTrials.gov Archive Site
  • Virologic efficacy [ Time Frame: At Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Treatment related toxicity [ Time Frame: At Weeks 48 and 96 ] [ Designated as safety issue: Yes ]
  • Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • CD4 counts and HIV-1 RNA viral load [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Treatment discontinuation, defined as premature discontinuation of participation in the study, failure to take ARV therapy for 8 or more consecutive weeks, or to switch to another ARV regimen for any reason during the full course of the study [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Genotypic resistance measured by at least 1 genotypic mutation associated with resistance among subjects with a confirmed virologic failure (as described previously) and evaluation of genotypic drug resistance patterns [ Time Frame: At Weeks 24 and 96 ] [ Designated as safety issue: No ]
  • Treatment adherence, defined by 95% or greater of prescribed pills taken [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Quality of life as measured by items and patterns of responses to the FAHI questionnaire [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • HIV-1 DNA and RNA measurements [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Efavirenz
    600 mg tablet taken orally daily
    Other Name: EFV
  • Drug: Lamivudine/zidovudine
    150mg lamivudine/300mg zidovudine tablet taken orally twice daily
    Other Name: 3TC/ZDV
Experimental: 1
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.
Interventions:
  • Drug: Efavirenz
  • Drug: Lamivudine/zidovudine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Senegal
 
NCT00100568
CIPRA-SN-001, SN-CIPRA-001, 10412
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Study Chair: Souleymane Mboup, PharmD Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP