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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)
This study is currently recruiting participants.
Study NCT00346567   Information provided by Rigshospitalet, Denmark
First Received: June 29, 2006   Last Updated: February 17, 2009   History of Changes

June 29, 2006
February 17, 2009
June 2006
November 2010   (final data collection date for primary outcome measure)
  • frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
  • frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
  • frequency of mother-to-child HIV transmission
  • frequency of NNRTI resistance development
Complete list of historical versions of study NCT00346567 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia
  • Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D
 
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)
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)

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.

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.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
HIV Infections
  • Drug: Zidovudine and Lamivudine (Combivir)
  • Drug: Emtricitabine and Tenofovir (Truvada)
  • Active Comparator: AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
  • Experimental: AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
450
November 2010
November 2010   (final data collection date for primary outcome measure)

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 200 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
Female
18 Years to 55 Years
No
Contact: Terese L Katzenstein, MD, Ph.D. +45 35 45 14 92 katzenstein@dadlnet.dk
Contact: Jan Gerstoft, M.D. DMSc. + 45 35 45 77 44 gerstoft@rh.dk
Tanzania
 
NCT00346567
Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet
comtru
Rigshospitalet, Denmark
University of Copenhagen
Study Director: Terese L Katzenstein, MD Ph.D. Rigshospitalet, Copenhagen, Denmark
Rigshospitalet, Denmark
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP