| ID | Type | Description | Link |
|---|---|---|---|
| SN-CIPRA-001 | |||
| 10412 | Registry Identifier | DAIDS-ES |
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| Name | Class |
|---|---|
| Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV) | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz | Drug | 600 mg tablet taken orally daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Souleymane Mboup, PharmD | Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National Hospitalier de Fann, Dakar CIPRA CRS | Dakar | Senegal | ||||
| Institut d'Hygiène Sociale, Dakar CIPRA CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10449294 | Background | 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. | |
| 15472858 | Background | 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. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
| C109078 | lamivudine, zidovudine drug combination |
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| Lamivudine/zidovudine | Drug | 150mg lamivudine/300mg zidovudine tablet taken orally twice daily |
|
|
| 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 |
| 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 |
| 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 |
| Treatment adherence, defined by 95% or greater of prescribed pills taken | Throughout study |
| Quality of life as measured by items and patterns of responses to the FAHI questionnaire | Throughout study |
| HIV-1 DNA and RNA measurements | Throughout study |
| Dakar |
| Senegal |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |