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)

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Drug: Emtricitabine and Tenofovir (Truvada); Drug: Zidovudine and Lamivudine (Combivir)

• Registration Number: NCT00346567
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed 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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-29
• Study First Submitted QC: 2006-06-29
• Study First Posted: 2006-06-30
• Status Verified: 2009-02
• Primary Completion: 2010-10
• Study Completion: 2011-04
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 566

Inclusion Criteria

• HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.

Exclusion Criteria

• CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
• Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Emtricitabine and Tenofovir (Truvada)	AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
1	Zidovudine and Lamivudine (Combivir)	AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily

Primary Outcome Measures

Name	Time	Method
frequency of mother-to-child HIV transmission	6 weeks post partum
frequency of NNRTI resistance development	6 weeks post partum

Secondary Outcome Measures

Name	Time	Method
Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia	Delivery, day 7, day 42 and month 9 post partum
Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D	Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child

Trial Locations

Locations (1)

Bombo Regional Hospital; 🇹🇿 Tanga, Tanzania