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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 has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00346567
First received: June 29, 2006
Last updated: August 24, 2012
Last verified: February 2009

June 29, 2006
August 24, 2012
June 2006
October 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
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Drug: Zidovudine and Lamivudine (Combivir)
  • Drug: Emtricitabine and Tenofovir (Truvada)
  • Active Comparator: 1
    AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
    Intervention: Drug: Zidovudine and Lamivudine (Combivir)
  • Experimental: 2
    AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
    Intervention: Drug: Emtricitabine and Tenofovir (Truvada)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
566
April 2011
October 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 information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00346567
comtru
Not Provided
Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet
Rigshospitalet, Denmark
University of Copenhagen
Study Director: Terese L Katzenstein, MD Ph.D. Rigshospitalet, Denmark
Rigshospitalet, Denmark
February 2009

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