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Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-Child Transmission (PMTCT)

2014-08-27 03:43:43 | BioPortfolio

Summary

The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development.

Description

Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

HIV Infections

Intervention

Zidovudine and Lamivudine (Combivir), Emtricitabine and Tenofovir (Truvada)

Location

Bombo Regional Hospital
Tanga
Tanzania

Status

Recruiting

Source

Rigshospitalet, Denmark

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:43-0400

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