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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.
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: June 29, 2006
Last updated: February 22, 2016
Last verified: February 2009
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.

Condition Intervention
HIV Infections
Drug: Zidovudine and Lamivudine (Combivir)
Drug: Emtricitabine and Tenofovir (Truvada)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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)

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ]
  • frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

Enrollment: 566
Study Start Date: June 2006
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Zidovudine and Lamivudine (Combivir)
Experimental: 2
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
Drug: Emtricitabine and Tenofovir (Truvada)

Detailed 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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00346567

Bombo Regional Hospital
Tanga, Tanzania
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Study Director: Terese L Katzenstein, MD Ph.D. Rigshospitalet, Denmark
  More Information

Responsible Party: Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet Identifier: NCT00346567     History of Changes
Other Study ID Numbers: comtru
Study First Received: June 29, 2006
Last Updated: February 22, 2016

Keywords provided by Rigshospitalet, Denmark:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimetabolites processed this record on April 28, 2017