drugset / Trial / NCT00146380
A Study of Zidovudine/Lamivudine and Either Nevirapine or Nelfinavir for Reduction of Mother-to-child HIV Transmission During Breastfeeding
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of the study is to demonstrate that a regimen using highly active antiretroviral therapy (HAART) to maximally suppress maternal viral load in the late antenatal period and during the first six months of lactation is safe, effective and can be implemented in resource poor settings in order to reduce the risk of HIV transmission to the infant.
Timeline
- Start
- 2003-07
- Primary completion
- 2009-01
- Completion
- 2013-01
Publications
- Zeh C, Weidle PJ, Nafisa L, Lwamba HM, Okonji J, Anyango E, Bondo P, Masaba R, Fowler MG, Nkengasong JN, Thigpen MC, Thomas T. HIV-1 drug resistance emergence among breastfeeding infants born to HIV-infected mothers during a single-arm trial of triple-antiretroviral prophylaxis for prevention of mother-to-child transmission: a secondary analysis. PLoS Med. 2011 Mar;8(3):e1000430. doi: 10.1371/journal.pmed.1000430. Epub 2011 Mar 29.
- Thomas TK, Masaba R, Borkowf CB, Ndivo R, Zeh C, Misore A, Otieno J, Jamieson D, Thigpen MC, Bulterys M, Slutsker L, De Cock KM, Amornkul PN, Greenberg AE, Fowler MG; KiBS Study Team. Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding--the Kisumu Breastfeeding Study, Kenya: a clinical trial. PLoS Med. 2011 Mar;8(3):e1001015. doi: 10.1371/journal.pmed.1001015. Epub 2011 Mar 29.
- Harris JR, Greene SK, Thomas TK, Ndivo R, Okanda J, Masaba R, Nyangau I, Thigpen MC, Hoekstra RM, Quick RE. Effect of a point-of-use water treatment and safe water storage intervention on diarrhea in infants of HIV-infected mothers. J Infect Dis. 2009 Oct 15;200(8):1186-93. doi: 10.1086/605841.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 150 mg | Oral |
| Subject | Nelfinavir | Other / unclassified | 1250 mg | Oral |
| Subject | Nevirapine | Small molecule | 200 mg | Oral |
| Subject | Zidovudine | Small molecule | 300 mg | Oral |