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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT)

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Zidovudine and Lamivudine (Combivir)
* Drug: Emtricitabine and Tenofovir (Truvada)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily | Drug: Zidovudine and Lamivudine (Combivir)<br> <br> |
| Experimental: 2<br>AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP | Drug: Emtricitabine and Tenofovir (Truvada)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of mother-to-child HIV transmission |  | 6 weeks post partum | 
| frequency of NNRTI resistance development |  | 6 weeks post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mother-to-child-transmission, PMTCT, HIV, resistance, NNRTI