Backup With Combivir or Single Dose (Sd) Truvada in Order to Avoid NNRTI Resistance After Sd Nevirapine for the PMTCT - Full Text View

Backup With Combivir or Single Dose (Sd) Truvada in Order to Avoid NNRTI Resistance After Sd Nevirapine for the PMTCT

This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, June 2006

Sponsors and Collaborators:	Rigshospitalet, Denmark University of Copenhagen
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00346567

Purpose

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	Drug: nevirapine combivir (AZT/3TC) truvada (FTC/TDF) drugs

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Lamivudine Nevirapine Truvada Combivir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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)

Further study details as provided by Rigshospitalet, Denmark:

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

Estimated Enrollment:	300
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2008

Detailed Description:

Randomised open study comparing single dose nevirapine + 1 week of combivir with single dose nevirapine with one 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. N = 300. The study will be conducted at Ngamiani and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346567

Contacts


Contact: Terese L Katzenstein, MD, Ph.D.	+45 35 45 14 92	katzenstein@dadlnet.dk

Contact: Jan Gerstoft, M.D. DMSc.	+ 45 35 45 77 44	gerstoft@rh.dk

Locations


Tanzania
	Bombo Regional Hospital	Recruiting
	Tanga, Tanzania
	Sub-Investigator: Martha Lemnge, Ph.D.
	Principal Investigator: Celine Mandara, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

University of Copenhagen

Investigators


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

More Information

Study ID Numbers:	comtru
First Received:	June 29, 2006
Last Updated:	June 29, 2006
ClinicalTrials.gov Identifier:	NCT00346567
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:

mother-to-child-transmission

PMTCT

HIV

resistance

NNRTI

Study placed in the following topic categories:

Nevirapine

HIV Infections

Acquired Immunodeficiency Syndrome

Lamivudine

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-HIV Agents

Molecular Mechanisms of Pharmacological Action

Anti-Retroviral Agents

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Nucleic Acid Synthesis Inhibitors

Pharmacologic Actions

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008