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)

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ClinicalTrials.gov Identifier: NCT00346567

Recruitment Status : Completed

First Posted : June 30, 2006

Last Update Posted : February 23, 2016

Sponsor:

Collaborator:

University of Copenhagen

Information provided by:

Rigshospitalet, Denmark

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Zidovudine and Lamivudine (Combivir) Drug: Emtricitabine and Tenofovir (Truvada)	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	566 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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)
Study Start Date :	June 2006
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Truvada

U.S. FDA Resources

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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

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 ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes 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 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346567

Locations


Tanzania
Bombo Regional Hospital
Tanga, Tanzania

Sponsors and Collaborators

Rigshospitalet, Denmark

University of Copenhagen

Investigators


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

More Information


Responsible Party:	Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet
ClinicalTrials.gov Identifier:	NCT00346567 History of Changes
Other Study ID Numbers:	comtru
First Posted:	June 30, 2006 Key Record Dates
Last Update Posted:	February 23, 2016
Last Verified:	February 2009

Keywords provided by Rigshospitalet, Denmark:


mother-to-child-transmission PMTCT HIV resistance NNRTI

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Emtricitabine Zidovudine Nevirapine	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers

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