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)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346567
• Other study ID #: comtru
• Status: Completed
• Phase: N/A
• First received: June 29, 2006
• Last updated: February 22, 2016
• Start date: June 2006
• Est. completion date: April 2011

Study information

• Verified date: February 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Zidovudine and Lamivudine (Combivir)

• Emtricitabine and Tenofovir (Truvada)

Locations

Country	Name	City	State
Tanzania	Bombo Regional Hospital	Tanga

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	University of Copenhagen

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of mother-to-child HIV transmission		6 weeks post partum	No
Primary	frequency of NNRTI resistance development		6 weeks post partum	No
Secondary	Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia		Delivery, day 7, day 42 and month 9 post partum	No
Secondary	Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D		Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child	No