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
  Purpose

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 Intervention
HIV Infections
Drug: Efavirenz
Drug: Lamivudine/zidovudine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00100568

Locations
Senegal
Centre National Hospitalier de Fann, Dakar CIPRA CRS
Dakar, Senegal
Institut d'Hygiène Sociale, Dakar CIPRA CRS
Dakar, Senegal
Sponsors and Collaborators
Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
Investigators
Study Chair: Souleymane Mboup, PharmD Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00100568     History of Changes
Obsolete Identifiers: NCT00738465
Other Study ID Numbers: CIPRA-SN-001, SN-CIPRA-001, 10412
Study First Received: January 3, 2005
Last Updated: September 4, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Efavirenz
Lamivudine
Zidovudine
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on October 19, 2014