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

NCT ID: NCT00100568

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-06-30

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.

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.

Conditions

HIV Infections

Keywords

Treatment Naive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Efavirenz

Intervention Type: DRUG

600 mg tablet taken orally daily

Lamivudine/zidovudine

Intervention Type: DRUG

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

Interventions

Efavirenz

600 mg tablet taken orally daily

Intervention Type: DRUG

Lamivudine/zidovudine

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

Intervention Type: DRUG

Other Intervention Names

EFV; 3TC/ZDV

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Souleymane Mboup, PharmD

Role: STUDY_CHAIR

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

Locations

Centre National Hospitalier de Fann, Dakar CIPRA CRS

Dakar, , Senegal

Institut d'Hygiène Sociale, Dakar CIPRA CRS

Dakar, , Senegal

Countries

Senegal

References

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.

Reference Type: BACKGROUND

PMID: 10449294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15472858 (View on PubMed)

Other Identifiers

SN-CIPRA-001

Identifier Type: -

Identifier Source: secondary_id

10412

Identifier Type: REGISTRY

Identifier Source: secondary_id

CIPRA-SN-001

Identifier Type: -

Identifier Source: org_study_id

NCT00738465

Identifier Type: -

Identifier Source: nct_alias