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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Microbicide Trials Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00540605 |
A new approach to HIV prevention currently being studied includes the use of topical microbicides, substances that kill microbes. The purpose of this study is to determine the levels of tenofovir, a microbicide in gel form, in HIV uninfected pregnant women who are expecting to deliver by cesarean.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tenofovir 1% vaginal gel |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas |
Estimated Enrollment: | 16 |
Study Start Date: | June 2008 |
Arms | Assigned Interventions |
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1: Experimental
4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery
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Drug: Tenofovir 1% vaginal gel
topical gel containing 1% tenofovir
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There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides represent one such method. Tenofovir 1% vaginal gel was chosen as a high priority microbicide candidate due to its activity in target cells for HIV infection of the vagina and cervix and the low frequency of local and systemic toxicity observed in a prior HIV Prevention Trials Network (HPTN) trial utilizing tenofovir 1% gel. The purpose of this study is to assess term pregnancy single-dose pharmacokinetics (PK) of tenofovir 1% gel in HIV uninfected pregnant women.
The expected duration of participation for individually enrolled participants will depend on how early they enroll prior to the date of cesarean section, but may range from approximately 3 to 6 weeks. An initial screening/enrollment visit will occur approximately 1 to 4 weeks prior to the participant's scheduled cesarean section, but no more than 4 weeks before the delivery date. A targeted physical exam, medical and medication history assessment, blood and urine collection, and a pelvic exam will occur at screening/enrollment. Tenofovir gel will be administered vaginally approximately 2 hours before the expected time of cesarean section. On the day of gel administration and cesarean delivery, a targeted physical exam, medical and medication history assessment, a pelvic exam, maternal blood tenofovir level measurement, and collection of placental and endometrial tissues, cord blood, and amniotic fluid will occur.
After gel administration, PK measures will be taken at Hours 1, 2, 4, 6, 8, and 12; maternal blood tenofovir level measurement and a review of adverse events will also occur at these times. A 24-hour evaluation will occur between Hours 22 and 26. At this evaluation, a targeted physical exam, a review of adverse events, and tenofovir level measurement will occur. Each participant will be contacted between Days 10 and 18 to collect data on any adverse events they experience. In addition, an unscheduled visit may be necessary if an unresolved adverse event occurs on or after the 24-hour evaluation. If an unscheduled visit is required, the participant will undergo a targeted physical exam, medical and medication history assessment, blood and urine collection, a pelvic exam, and tenofovir level measurement.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Mitchell Creinin, MD 412-641-1441 mcreinin@mail.magee.edu | |
Pittsburgh CRS | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Christine A. Tripoli, BSN, RN 412-647-0771 tripolica@upmc.edu | |
Principal Investigator: Sharon A. Riddler, MD |
Study Chair: | Richard Beigi, MD, MSc, FACOG | Magee-Women's Hospital of UPMC, Department of Obstetrics/Gynecology |
Principal Investigator: | Sharon Hillier, PhD | Microbicides Trial Network |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | MTN-002, 1-U01-AI068633-0 |
Study First Received: | October 5, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00540605 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Microbicide Pregnancy HIV Seronegativity |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Healthy Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |