Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP

NCT00204308 | Completed Phase 2 DMC

• 1 other identifier: EGSA 19-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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).

Conditions

HIV; Pregnancy

Keywords

HIV; Pregnancy; Mother-to-child transmission of HIV; Drug resistance; Nevirapine resistance; NNRTI resistance

Outcome Measures

Primary Outcomes (1)

• maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors

  6 weeks

Secondary Outcomes (2)

• maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors

  2 weeks

• maternal hematological and renal function after TDF-FTC use

  6 weeks

Study Arms (2)

combination tenofovir-emtricitabine

EXPERIMENTAL

Drug: Combination tenofovir-emtricitabine

control arm

NO INTERVENTION

Interventions

Combination tenofovir-emtricitabine DRUG

Tenofovir disoproxil 300 mg / emtricitabine 200 mg taken as a single dose during labor

Also known as: Truvada

combination tenofovir-emtricitabine

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator

Study Sites (2)

Kalingalinga Health Centre

Lusaka, Zambia

Location

Kanyama Health Centre

Lusaka, Zambia

Location

Related Publications (4)

• Chi BH, Sinkala M, Mbewe F, Cantrell RA, Kruse G, Chintu N, Aldrovandi GM, Stringer EM, Kankasa C, Safrit JT, Stringer JS. Single-dose tenofovir and emtricitabine for reduction of viral resistance to non-nucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomised trial. Lancet. 2007 Nov 17;370(9600):1698-705. doi: 10.1016/S0140-6736(07)61605-5. Epub 2007 Nov 7.

  PMID: 17997151 RESULT

• Chi BH, Chintu N, Cantrell RA, Kankasa C, Kruse G, Mbewe F, Sinkala M, Smith PJ, Stringer EM, Stringer JS. Addition of single-dose tenofovir and emtricitabine to intrapartum nevirapine to reduce perinatal HIV transmission. J Acquir Immune Defic Syndr. 2008 Jun 1;48(2):220-3. doi: 10.1097/QAI.0b013e3181743969.

  PMID: 18520682 RESULT

• Chi BH, Ellis GM, Chintu N, Cantrell RA, Sinkala M, Aldrovandi GM, Warrier R, Mbewe F, Nakamura K, Stringer EM, Frenkel LM, Stringer JS. Intrapartum tenofovir and emtricitabine reduces low-concentration drug resistance selected by single-dose nevirapine for perinatal HIV prevention. AIDS Res Hum Retroviruses. 2009 Nov;25(11):1099-106. doi: 10.1089/aid.2009.0088.

  PMID: 19886836 RESULT

• Dorton BJ, Mulindwa J, Li MS, Chintu NT, Chibwesha CJ, Mbewe F, Frenkel LM, Stringer JS, Chi BH. CD4+ cell count and risk for antiretroviral drug resistance among women using peripartum nevirapine for perinatal HIV prevention. BJOG. 2011 Mar;118(4):495-9. doi: 10.1111/j.1471-0528.2010.02835.x. Epub 2010 Dec 24.

  PMID: 21199294 RESULT

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jeffrey S A Stringer, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Benjamin H Chi, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

ZA (2)