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)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Rigshospitalet, Denmark. Recruitment status was Recruiting

First Received on June 29, 2006. Last Updated on February 17, 2009 History of Changes

Sponsor:	Rigshospitalet, Denmark
Collaborator:	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 Infections	Drug: Zidovudine and Lamivudine (Combivir) Drug: Emtricitabine and Tenofovir (Truvada)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Nevirapine Lamivudine Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	June 2006
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 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.

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, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.

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: Mercy G Chiduo, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

University of Copenhagen

Investigators

Study Director:

Terese L Katzenstein, MD Ph.D.

Rigshospitalet Copenhagen Denmark

More Information

No publications provided

Responsible Party:	Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet
ClinicalTrials.gov Identifier:	NCT00346567 History of Changes
Other Study ID Numbers:	comtru
Study First Received:	June 29, 2006
Last Updated:	February 17, 2009
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:

mother-to-child-transmission
PMTCT
HIV
resistance
NNRTI

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Nevirapine
Lamivudine

Reverse Transcriptase Inhibitors
Tenofovir
Lamivudine, zidovudine drug combination
Emtricitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2012