Back to results

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)

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

Tanzania

Study Type

Interventional

Intervention

Zidovudine and Lamivudine (Combivir)

Emtricitabine and Tenofovir (Truvada)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring mother-to-child-transmission, PMTCT, HIV, resistance, NNRTI

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Bombo Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily

AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP

Outcomes

Primary Outcome Measures

frequency of mother-to-child HIV transmission

frequency of NNRTI resistance development

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00346567

First Posted

June 29, 2006

Last Updated

February 22, 2016

Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00346567

Brief Title

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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

University of Copenhagen

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

mother-to-child-transmission, PMTCT, HIV, resistance, NNRTI

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

566 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily

Arm Title

Arm Type

Experimental

Arm Description

AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP

Intervention Type

Drug

Intervention Name(s)

Zidovudine and Lamivudine (Combivir)

Intervention Type

Drug

Intervention Name(s)

Emtricitabine and Tenofovir (Truvada)

Primary Outcome Measure Information:

Title

frequency of mother-to-child HIV transmission

Time Frame

6 weeks post partum

Title

frequency of NNRTI resistance development

Time Frame

6 weeks post partum

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terese L Katzenstein, MD Ph.D.

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Director

Facility Information:

Facility Name

Bombo Regional Hospital

City

Tanga

Country

Tanzania

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs