Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
Public ClinicalTrials.gov record NCT00076791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
Study identification
- NCT ID
- NCT00076791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2004 (Type not available)
- Primary completion
- Mar 2010 (Actual)
- Completion
- Mar 2011 (Actual)
- Last update posted
- Nov 1, 2021
2004 – 2011
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's National Med. Ctr. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20010 | — |
| Washington Hosp. Ctr. NICHD CRS | Washington D.C. | District of Columbia | 20010 | — |
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami | Florida | 33136 | — |
| Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program | Chicago | Illinois | 60608 | — |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | — |
| NJ Med. School CRS | Newark | New Jersey | 07101-1709 | — |
| Nyu Ny Nichd Crs | New York | New York | 10016 | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| Hahnemann Univ. Hosp. | Philadelphia | Pennsylvania | 19102-1192 | — |
| Regional Med. Ctr. at Memphis | Memphis | Tennessee | — | — |
| St. Jude/UTHSC CRS | Memphis | Tennessee | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00076791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 1, 2021 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00076791 live on ClinicalTrials.gov.