Skip to main content
OpenTrials
Completed

NCT Number: NCT00346567

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bombo Regional Hospital

Tanga, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zidovudine and Lamivudine (Combivir)

Drug

Emtricitabine and Tenofovir (Truvada)

Drug

Primary outcomes

  1. frequency of mother-to-child HIV transmission

    Time frame: 6 weeks post partum

  2. frequency of NNRTI resistance development

    Time frame: 6 weeks post partum

Secondary outcomes

  1. Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia

    Time frame: Delivery, day 7, day 42 and month 9 post partum

  2. Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D

    Time frame: Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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)

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jun 30, 2006
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.