HIV InfectionsPhase 1NCT00540605
Blood Levels of Tenofovir Gel in HIV Uninfected Pregnant Women Planning Cesarean Delivery
A Phase 1 study testing Tenofovir 1% vaginal gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir 1% vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Tenofovir 1% vaginal gel
- Keywords
- Microbicide, Pregnancy, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir 1% vaginal gelDrug
topical gel containing 1% tenofovir
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery Receives: Drug: Tenofovir 1% vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax)
Measured: Throughout study
Endometrial tenofovir levels
Measured: 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)
Measured: At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Microbicide Trials Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Richard Beigi, MD, MSc, FACOG, Study chair, Magee-Women's Hospital of UPMC, Department of Obstetrics/GynecologySharon Hillier, PhD, Principal investigator, Microbicides Trial Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540605
- Sponsor's protocol ID
- MTN-002
- Other IDs
- 10600, 1-U01-AI068633-0, 1U01AI068633
- Status last verified
- May 2012
- First submitted
- 5 Oct 2007
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17852000Mayer 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.
PubMed 16470118Beigi 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.
PubMed 21930612
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas
- ClinicalTrials.gov ID
- NCT00540605
- Acronym / sponsor ID
- MTN-002
- Conditions
- HIV Infections
- Keywords
- Microbicide, Pregnancy, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Microbicide Trials Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tenofovir 1% vaginal gel4g tenofovir 1% gel applied vaginally 2 hours prior to expected time of cesarean delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir 1% vaginal geltopical gel containing 1% tenofovir | Drug | 1 |
Primary outcome
Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax)
Time frame: Throughout study
Endometrial tenofovir levels
Time frame: 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)
Time frame: At Hours 1, 2, 4, 6, 8, 12, and 24 after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 17852000Carballo-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.
- Background: PubMed 16470118Mayer 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.
- Derived from this study: PubMed 21930612Beigi 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.
- Click here for the Microbicide Trials Network Web siteLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Beigi, MD, MSc, FACOG study chair
Magee-Women's Hospital of UPMC, Department of Obstetrics/Gynecology
Sharon Hillier, PhD principal investigator
Microbicides Trial Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir 1% vaginal gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal third trimester pharmacokinetic (PK) measures (AUC and Cmax) (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540605, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.