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NCT01136759 · ClinicalTrials.gov registry record · Phase 1
Tenofovir Gel in Pregnancy and Lactation
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 232
- Enrollment target
NCT01136759 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 232 participants.
The verdict
NCT01136759, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 232 participants
- Enrollment target
Study Summary
Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.
Interventions
- DRUG Tenofovir 1% gel
- OTHER Placebo gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01136759
The ClinicalTrials.gov registry entry for NCT01136759 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tenofovir 1% gel is the first listed.
NCT01136759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01136759 about?
NCT01136759 is a clinical study titled "Tenofovir Gel in Pregnancy and Lactation". Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbici...
What is the current status of trial NCT01136759?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 232 participants. The study started on 2011-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01136759?
The interventions under investigation include: Tenofovir 1% gel (DRUG), Placebo gel (OTHER).
Who is sponsoring clinical trial NCT01136759?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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