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

HIV Infections Clinical Trial

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

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

• HIV Infections

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

External Links

•   Click here for more information on adherence
•   Click here for more information on adhering to a regimen
•   Click here for more information on changing regimens
•   Click here for more information on efavirenz
•   Click here for more information on HIV regimen failure
•   Click here for more information on lamivudine/zidovudine
•   Haga clic aquí para ver información sobre este ensayo clínico en español.