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

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ClinicalTrials.gov Identifier: NCT00540605
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : May 18, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir 1% vaginal gel Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery
Drug: Tenofovir 1% vaginal gel
topical gel containing 1% tenofovir

Outcome Measures

Primary Outcome Measures :
  1. Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax) [ Time Frame: Throughout study ]
  2. Endometrial tenofovir levels [ Time Frame: At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration ]
  3. Placental transfer (cord blood tenofovir levels, placental tissue tenofovir levels, and amniotic fluid tenofovir levels) [ Time Frame: At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540605

United States, Pennsylvania
Pitt CRS
Pittsburgh, Pennsylvania, United States, 15213
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)
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
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00540605     History of Changes
Obsolete Identifiers: NCT00572273
Other Study ID Numbers: MTN-002
10600 ( Registry Identifier: DAIDS ES )
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents