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Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP (TD-2)

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ClinicalTrials.gov Identifier: NCT00204308
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 31, 2012
Sponsor:
Collaborator:
Elizabeth Glaser Pediatric AIDS Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The purpose of this study is to determine whether the addition of tenofovir (TDF) and emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can reduce the development of post-ingestion HIV resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Condition or disease Intervention/treatment Phase
HIV Pregnancy Drug: Combination tenofovir-emtricitabine Phase 2

Detailed Description:

Single-dose intrapartum and neonatal nevirapine (NVP), either alone or in combination with short course zidovudine (ZDV) is in widespread use to prevent mother-to-child HIV transmission throughout the developing world. Though the public health benefits cannot be overstated, widespread use of NVP in this fashion may come at a cost. Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations are induced in at least 20% and probably a larger proportion of women exposed to NVP in this fashion. Addition of short-course ZDV does not appear to mitigate this effect substantially. The full implications of these NVP resistance mutations are yet unknown, though there is concern that they may result in reduced efficacy of the NVP or other NNRTIs in long-term, therapeutic regimens.

We are conducting a clinical trial of tenofovir (TDF) and emtricitabine (FTC), marketed as a fixed dose combination, Truvada ™, to reduce NNRTI-resistance post-delivery in the setting of NVP with or without ZDV for PMTCT. TDF and FTC are both Category B drugs and are approved for use in pregnancy. They have several characteristics that make them ideal candidate drugs for use in conjunction with NVP, including long intracellular half-lives and established safety profile among adults for HIV treatment.

Women will be enrolled between 28 and 38 weeks of gestation. As part of normal PMTCT services, they may choose NVP-boosted ZDV or single dose NVP for PMTCT; We anticipate that most (~80%) will choose the former. At arrival for delivery, they will be randomized to receive either the two study drugs (intervention) or no drug (control). A total of 400 women will be randomized, and followed, along with their infants, for 6 months.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission
Study Start Date : March 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: combination tenofovir-emtricitabine Drug: Combination tenofovir-emtricitabine
Tenofovir disoproxil 300 mg / emtricitabine 200 mg taken as a single dose during labor
Other Name: Truvada
No Intervention: control arm


Outcome Measures
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Primary Outcome Measures :
  1. maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors [ Time Frame: 2 weeks ]
  2. maternal hematological and renal function after TDF-FTC use [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serologically confirmed HIV infection;
  • Gestational age of 28 to 38 weeks;
  • Previous selection of a NVP-based PMTCT regimen (with or without ZDV)
  • Willingness to participate in a randomized trial;
  • Willingness to follow up in a postpartum visit schedule;
  • Willingness to allow her infant to participate in this trial;

Exclusion Criteria:

  • Use of antiretroviral medications before this pregnancy, even in a single dose.
  • Current use of antiretroviral medications for treatment of advanced HIV disease and/or AIDS
  • Illness or complication of pregnancy likely to warrant transfer to the University Teaching Hospital (UTH), known at time of randomization;
  • Known or suspected allergy to NVP or other benzodiazepine medications;
  • History of known liver disease.
  • Hemoglobin level of 7.9 g/dL or less
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00204308


Locations
Zambia
Kalingalinga Health Centre
Lusaka, Zambia
Kanyama Health Centre
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Elizabeth Glaser Pediatric AIDS Foundation
Investigators
Principal Investigator: Jeffrey S A Stringer, MD University of Alabama at Birmingham
Study Director: Benjamin H Chi, MD University of Alabama at Birmingham
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Benjamin Chi, MD, MSc, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00204308     History of Changes
Other Study ID Numbers: EGSA 19-02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012

Keywords provided by Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill:
HIV
Pregnancy
Mother-to-child transmission of HIV
 Drug resistance
Nevirapine resistance
NNRTI resistance

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Nevirapine
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
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers