Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery

NCT00540605 | Completed Phase 1 DMC

• 4 other identifiers: MTN-002106001-U01-AI068633-01U01AI068633
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

Microbicide; Pregnancy; HIV Seronegativity

Outcome Measures

Primary Outcomes (3)

• Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax)

  Throughout study

• Endometrial tenofovir levels

  At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration

• Placental transfer (cord blood tenofovir levels, placental tissue tenofovir levels, and amniotic fluid tenofovir levels)

  At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration

Study Arms (1)

1

EXPERIMENTAL

4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery

Drug: Tenofovir 1% vaginal gel

Interventions

Tenofovir 1% vaginal gel DRUG

topical gel containing 1% tenofovir

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Microbicide Trials Network: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Pitt CRS

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Carballo-Dieguez A, Balan 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. doi: 10.1080/09540120701294237.

  PMID: 17852000 BACKGROUND

• Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse 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. doi: 10.1097/01.aids.0000210608.70762.c3.

  PMID: 16470118 BACKGROUND

• Beigi R, Noguchi L, Parsons T, Macio I, Kunjara Na Ayudhya RP, Chen J, Hendrix CW, Masse B, Valentine M, Piper J, Watts DH. Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. J Infect Dis. 2011 Nov 15;204(10):1527-31. doi: 10.1093/infdis/jir562. Epub 2011 Sep 19.

  PMID: 21930612 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Richard Beigi, MD, MSc, FACOG

  Magee-Women's Hospital of UPMC, Department of Obstetrics/Gynecology

  STUDY CHAIR

• Sharon Hillier, PhD

  Microbicides Trial Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Completion: January 1, 2010
• Last Updated: October 25, 2021

Record last verified: 2012-05

Locations

US (1)