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

Condition(s) targeted: HIV Infections

Intervention: Efavirenz (Drug); Lamivudine/zidovudine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Souleymane Mboup, PharmD, Study Chair, Affiliation: Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml measured by Week 24 and confirmed by repeat testing within 30 days

treatment-related toxicity of Grade 3 or higher at any time during the first 24 weeks of treatment, as measured by development of drug-related toxicities severe enough to warrant dose modification, interruption, or permanent discontinuation

Secondary outcome:

Virologic efficacy measured at Weeks 48 and 96

treatment related toxicity at any time during the first 48 or 96 weeks of treatment

virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml measured at Weeks 24, 48, and 96, confirmed by repeat testing within 30 days

CD4 counts and HIV-1 RNA viral load measured at entry and Weeks 12, 24, 36, 48, 72, and 96

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

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

genotypic resistance measured by at least 1 genotypic mutation associated with resistance among subjects with a confirmed virologic failure (as described previously) at Weeks 24 and 96 and evaluation of genotypic drug resistance patterns

treatment adherence, defined by 95% or greater of prescribed pills taken, based on interviews at Weeks 12, 24, 48, and 96

quality of life as measured by items and patterns of responses to the FAHI questionnaire at baseline and Weeks 24, 48, 72, and 96

HIV-1 DNA and RNA measurements taken during the study at study entry and Weeks 12, 24, 36, 48, 72, and 96

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV-1 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

Click here for more information on efavirenz

Click here for more information on lamivudine/zidovudine

Click here for more information on HIV regimen failure

Click here for more information on changing regimens

Click here for more information on adherence

Click here for more information on adhering to a regimen

Haga clic aquí para ver información sobre este ensayo clínico en español.

Related publications:

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.

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.

Starting date: October 2005
Last updated: January 27, 2006