Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tenofovir 1% vaginal gel (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Richard Beigi, MD, MSc, FACOG, Study Chair, Affiliation: Magee-Women's Hospital of UPMC, Department of Obstetrics/Gynecology Sharon Hillier, PhD, Principal Investigator, Affiliation: Microbicides Trial Network
Summary
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.
Clinical Details
Official title: Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax)Endometrial tenofovir levels Placental transfer (cord blood tenofovir levels, placental tissue tenofovir levels, and amniotic fluid tenofovir levels)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- General good health
- HIV uninfected
- Hepatitis B surface antigen negative at screening and enrollment
- Viable, single pregnancy delivered by cesarean section planned between 37 0/7 to 41
6/7 weeks of pregnancy
- Normal Pap smear in the 12 months prior to study entry
- Willing to abstain from vaginal, anal, and receptive oral sex for at least 2 weeks
after gel administration
- Willing to abstain from intravaginal products and practices (including douching)
during study participation
Exclusion Criteria:
- Maternal or fetal condition that requires urgent cesarean section
- Documented rupture of the amniotic membranes
- Known disease in the mother that has a predictable negative effect on placental
function
- Known placental/fetal abnormalities that could affect placental transfer. More
information on this criterion can be found in the protocol.
- Previously demonstrated hypersensitivity to any components of tenofovir 1% gel
- Certain abnormal laboratory values
- Use of vaginal medications within 48 hours of study entry
- Untreated sexually transmitted infection (STI) or exposure to partner's STI,
including chlamydia, gonorrhea, trichomoniasis, and nongonococcal urethritis
- Symptomatic vaginitis, including bacterial vaginosis and vulvovaginal candidiasis.
Participants with asymptomatic signs of bacterial vaginosis and/or yeast not
excluded.
- Participation in any other investigational drug or device trial within 30 days of
study entry
- Any social or medical condition that, in the opinion of the investigator, would
interfere with the study
Locations and Contacts
Pitt CRS, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Click here for more information on tenofovir Click here for the Microbicide Trials Network Web site Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: Carballo-Diéguez A, Balán IC, Morrow K, Rosen R, Mantell JE, Gai F, Hoffman S, Maslankowski L, El-Sadr W, Mayer K. Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a Phase I clinical trial (HPTN 050). AIDS Care. 2007 Sep;19(8):1026-31. Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Mâsse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51.
Last updated: May 17, 2012
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