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)

February 22, 2016 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

566

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Tanga, Tanzania
        • Bombo Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of mother-to-child HIV transmission
Time Frame: 6 weeks post partum
6 weeks post partum
frequency of NNRTI resistance development
Time Frame: 6 weeks post partum
6 weeks post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen

Investigators

  • Study Director: Terese L Katzenstein, MD Ph.D., Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

June 30, 2006

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • comtru

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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