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)

Rigshospitalet

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Zidovudine and Lamivudine (Combivir); Drug: Emtricitabine and Tenofovir (Truvada)

Study type: Interventional

Funder types: Other

Identifiers

NCT00346567

comtru

Details and patient eligibility

About

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.

Full 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.

Enrollment: 566 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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566 participants in 2 patient groups

1

Active Comparator group

Description:

AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily

Treatment:

Drug: Zidovudine and Lamivudine (Combivir)

2

Experimental group

Description:

AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP

Treatment:

Drug: Emtricitabine and Tenofovir (Truvada)