Tenofovir Gel in Pregnancy and Lactation
Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation
4 other identifiers
interventional
232
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Mar 2011
Typical duration for phase_1 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 25, 2021
September 1, 2014
2.5 years
June 2, 2010
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Safety and tolerability in pregnant women
Safety and tolerability in pregnant women are assessed by number of specific Grade 2 or greater adverse events in laboratory abnormalities, genital/pelvic signs/symptoms, or pregnancy complications
Measured at 2 weeks post-delivery
Safety and tolerability in infants, defined as no intensive care admission greater than 24 hours and no sepsis
Measured at 2 weeks post-delivery
Safety and tolerability in lactating women, defined as specific Grade 2 or greater adverse events in laboratory abnormalities or genital/pelvic signs/symptoms
Safety and tolerability in lactating women are assessed by number of specific Grade 2 or greater adverse events in laboratory abnormalities or genital/pelvic signs/symptoms
Measured at Day 14
Safety and tolerability in infants of lactating mothers
Safety and tolerability in infants of lactating mothers is defined as no inpatient admission (confirmed on review of medical records) with diagnosis of adverse event (AE) judged to be related to study product
Measured at Day 14
Tenofovir levels in maternal blood or breast milk
Measured at Day 6 or delivery, depending on cohort
Secondary Outcomes (3)
Presence of tenofovir in blood among infants of participants in the pregnancy and lactation cohorts
Measured at Day 6 or delivery, depending on cohort
Impact of tenofovir gel exposure on the presence of select organisms associated with neonatal sepsis among participants in the pregnancy cohort, (e.g., Group B β-hemolytic streptococcus, Escherichia coli)
Measured at Day 6
Adherence to daily use of tenofovir 1% gel for 7 days and its acceptability among pregnant and lactating women
Measured at Day 6
Study Arms (3)
Pregnancy cohort, placebo
PLACEBO COMPARATORPregnant women will receive placebo gel.
Lactation cohort, tenofovir gel
EXPERIMENTALLactating mothers will receive tenofovir gel.
Pregnancy cohort, tenofovir gel
EXPERIMENTALPregnant women will receive tenofovir gel.
Interventions
One applicator of tenofovir 1% gel administered vaginally for 7 consecutive days
One applicator of placebo gel administered vaginally for 7 consecutive days
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent to be screened for and take part in the study, including participation of the infant after delivery
- Willing and able to provide adequate locator information
- Willing and able to communicate in written and spoken English
- HIV uninfected
- Current pregnancy that is viable and a singleton
- Gestational age consistent with the following guidelines:
- For Pregnancy Cohort Group 1, between 37 0/7 and 39 1/7 weeks (inclusive) at the enrollment visit (Day 0)
- For Pregnancy Cohort Group 2, between 34 0/7 and 36 6/7 weeks (inclusive) at the enrollment visit (Day 0)
- Pap result consistent with Grade 0 or satisfactory evaluation of a non-Grade 0 Pap result, per clinical judgment of site investigator or record (IoR)/designee), in the 12 calendar months prior to enrollment
- Willing to abstain from using nonprescribed intravaginal products and practices (including douching and sex toys) or other investigational agent or device during study participation
You may not qualify if:
- History of adverse reaction to any component of tenofovir 1% gel
- Enrollment in any other investigational drug or device trial within 30 days prior to the enrollment visit (Day 0)
- Currently breastfeeding
- Use of vaginal medications within 48 hours prior to screening or enrollment (Day 0) (participant may return to complete study procedures after 48 hours have passed since use of vaginal medication)
- Documented to have any of the following during the current pregnancy:
- Ultrasound evidence of significant fetal congenital anomaly (in the opinion of the IoR or designee)
- Known rupture of the amniotic membranes
- Known placental/fetal abnormalities that could affect placental transfer (e.g., placental abruption, placenta previa, placenta accreta, intrauterine growth restriction, two-vessel cord, etc.)
- Known maternal disease with predictable negative effect on placental function (e.g., hypertension, diabetes mellitus, collagen vascular disease)
- Laboratory abnormalities noted at screening, as specified in study protocol
- Diagnosis of sexually transmitted infection (STI), including chlamydia, gonorrhea, and/or trichomoniasis, in the past 8 weeks prior to enrollment (Day 0), as assessed by participant report or review of medical record
- Clinically apparent pelvic exam finding of Grade 2 or higher (observed by study staff) at the enrollment visit
- Use of oral and/or vaginal preparations of antibiotic or antifungal medications at screening or within 7 days of enrollment (Day 0)
- Any social or medical condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
- Willing and able to provide written informed consent to be screened for and take part in the study
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Alabama CRS
Birmingham, Alabama, 35294, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213-2582, United States
Related Publications (2)
Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, Billitto N, Lynam JD, Pryke K, Graebing P, Hopkins N, Rooney JF, Friend D, Dezzutti CS. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One. 2010 Feb 19;5(2):e9310. doi: 10.1371/journal.pone.0009310.
PMID: 20174579BACKGROUNDCranage M, Sharpe S, Herrera C, Cope A, Dennis M, Berry N, Ham C, Heeney J, Rezk N, Kashuba A, Anton P, McGowan I, Shattock R. Prevention of SIV rectal transmission and priming of T cell responses in macaques after local pre-exposure application of tenofovir gel. PLoS Med. 2008 Aug 5;5(8):e157; discussion e157. doi: 10.1371/journal.pmed.0050157.
PMID: 18684007BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 3, 2010
Study Start
March 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 25, 2021
Record last verified: 2014-09