NCT00100568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2005

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

January 3, 2005

Last Update Submit

September 4, 2013

Conditions

HIV Infections

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (2)

  • Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml

    Through Week 24

  • 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

    Through Week 24

Secondary Outcomes (10)

  • Virologic efficacy

    At Weeks 48 and 96

  • Treatment related toxicity

    At Weeks 48 and 96

  • Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml

    Throughout study

  • CD4 counts and HIV-1 RNA viral load

    Throughout study

  • First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death

    Throughout study

  • +5 more secondary outcomes

Study Arms (1)

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.

Drug: EfavirenzDrug: Lamivudine/zidovudine

Interventions

EfavirenzDRUG

600 mg tablet taken orally daily

Also known as: EFV
1
Lamivudine/zidovudineDRUG

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

Also known as: 3TC/ZDV
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre National Hospitalier de Fann, Dakar CIPRA CRS

Dakar, Senegal

Location

Institut d'Hygiène Sociale, Dakar CIPRA CRS

Dakar, Senegal

Location

Related Publications (2)

  • Meda N, Ndoye I, M'Boup S, Wade A, Ndiaye S, Niang C, Sarr F, Diop I, Carael M. Low and stable HIV infection rates in Senegal: natural course of the epidemic or evidence for success of prevention? AIDS. 1999 Jul 30;13(11):1397-405. doi: 10.1097/00002030-199907300-00018.

    PMID: 10449294BACKGROUND

  • DeJesus E, Herrera G, Teofilo E, Gerstoft J, Buendia CB, Brand JD, Brothers CH, Hernandez J, Castillo SA, Bonny T, Lanier ER, Scott TR; CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004 Oct 1;39(7):1038-46. doi: 10.1086/424009. Epub 2004 Sep 10.

    PMID: 15472858BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenzlamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Souleymane Mboup, PharmD

    Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2005

First Posted

January 4, 2005

Study Start

July 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

SE(2)