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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00100568
Other study ID # CIPRA-SN-001
Secondary ID SN-CIPRA-0011041
Status Completed
Phase N/A
First received January 3, 2005
Last updated September 4, 2013
Start date July 2006
Est. completion date June 2009

Study information

Verified date September 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00738465

Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Efavirenz
600 mg tablet taken orally daily
Lamivudine/zidovudine
150mg lamivudine/300mg zidovudine tablet taken orally twice daily

Locations

Country Name City State
Senegal Centre National Hospitalier de Fann, Dakar CIPRA CRS Dakar
Senegal Institut d'Hygiène Sociale, Dakar CIPRA CRS Dakar

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)

Country where clinical trial is conducted

Senegal, 

References & Publications (2)

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. Epub 2004 Sep 10. — View Citation

Meda N, Ndoye I, M'Boup S, Wade A, Ndiaye S, Niang C, Sarr F, Diop I, Caraël 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml Through Week 24 No
Primary 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 Yes
Secondary Virologic efficacy At Weeks 48 and 96 No
Secondary Treatment related toxicity At Weeks 48 and 96 Yes
Secondary Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml Throughout study No
Secondary CD4 counts and HIV-1 RNA viral load Throughout study No
Secondary First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death Throughout study Yes
Secondary 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 Throughout study No
Secondary 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 At Weeks 24 and 96 No
Secondary Treatment adherence, defined by 95% or greater of prescribed pills taken Throughout study No
Secondary Quality of life as measured by items and patterns of responses to the FAHI questionnaire Throughout study No
Secondary HIV-1 DNA and RNA measurements Throughout study No
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