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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00204308
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP TD-2
• Scientific 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
• Date of first enrolment: March 2005
• Target sample size: 400
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00204308
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Zambia

Contacts

• Name: Benjamin H Chi, MD
• Affiliation: University of Alabama at Birmingham

• Name: Jeffrey S A Stringer, MD
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

HIV

Intervention(s)

Drug: Combination tenofovir-emtricitabine

Primary Outcome(s)

maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors [Time Frame: 6 weeks]

Secondary Outcome(s)

maternal antiretroviral drug resistance to non-nucloeoside reverse transcriptase inhibitors [Time Frame: 2 weeks]

maternal hematological and renal function after TDF-FTC use [Time Frame: 6 weeks]

Secondary ID(s)

EGSA 19-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Elizabeth Glaser Pediatric AIDS Foundation