Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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: NCT00100568
Recruitment Status : Completed
First Posted : January 4, 2005
Last Update Posted : September 6, 2013
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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.

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

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal
Study Start Date : July 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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

Primary Outcome Measures :
  1. Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml [ Time Frame: Through Week 24 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Virologic efficacy [ Time Frame: At Weeks 48 and 96 ]
  2. Treatment related toxicity [ Time Frame: At Weeks 48 and 96 ]
  3. Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml [ Time Frame: Throughout study ]
  4. CD4 counts and HIV-1 RNA viral load [ Time Frame: Throughout study ]
  5. First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death [ Time Frame: Throughout study ]
  6. 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 ]
  7. 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 ]
  8. Treatment adherence, defined by 95% or greater of prescribed pills taken [ Time Frame: Throughout study ]
  9. Quality of life as measured by items and patterns of responses to the FAHI questionnaire [ Time Frame: Throughout study ]
  10. HIV-1 DNA and RNA measurements [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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): NCT00100568

Layout table for location information
Centre National Hospitalier de Fann, Dakar CIPRA CRS
Dakar, Senegal
Institut d'Hygiène Sociale, Dakar CIPRA CRS
Dakar, Senegal
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Layout table for investigator information
Study Chair: Souleymane Mboup, PharmD Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur
Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00100568    
Obsolete Identifiers: NCT00738465
Other Study ID Numbers: CIPRA-SN-001
10412 ( Registry Identifier: DAIDS-ES )
First Posted: January 4, 2005    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Naive
Additional relevant MeSH terms:
Layout table for MeSH terms
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral 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