HIV InfectionsPhase 2NCT01490671

Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women

A Phase 2 study testing 1% tenofovir gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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?: 1% tenofovir gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Start not givento Aug 2015
Phase: Phase 2
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

Age 18 through 45 years (inclusive) at screening, verified per site standard operating procedures (SOPs)
At enrollment, singleton, viable pregnancy of gestational age within the limits for current group for enrollment
Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
Able and willing to provide the following:
Written informed consent to be screened for and take part in the study
Adequate locator information, as defined in site SOPs

Show all 14Show fewer

Adequate documentation of entry to antenatal care, as defined in site SOPs
Permission to contact and provision of adequate contact information for participant's antenatal care provider
Permission to obtain copies of antenatal care records More information on this criterion can be found in the protocol.
HIV-uninfected based on testing performed by study staff at screening and enrollment (per algorithm in protocol)
Per the clinical judgment of the Investigator of Record (IoR)/designee at enrollment, pelvic exam (including cervical exam) normal for estimated gestational age and parity
Per the clinical judgment of the IoR/designee at enrollment, ultrasound results are complete, consistent with normal singleton intrauterine pregnancy, and provide an assessment of gestational age. More information on this criterion can be found in the protocol.
Per participant mother report, willingness by the participant mother to receive information regarding and consider participation in MTN-016, a pregnancy registry study that collects additional information on pregnancy safety and the growth and development of babies up to 1 year of age
At screening and enrollment, agrees not to participate in other research studies involving drugs, vaccines, medical devices, or vaginal products for the duration of study participation

Who cannot join

Participant mother reported any of the following:
Prior exposure to gel or oral formulation of tenofovir (ever)
Known sensitivity to any component of the study products (ever)
Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to enrollment
Participation in any research study involving drugs, medical devices, or vaginal products during the current pregnancy
Non-therapeutic injection drug use in the 12 months prior to screening

Show all 41Show fewer

By participant mother report, noted on antenatal record, or clinical evidence at the time of enrollment of any of the following in the current pregnancy:
Multiple gestation
Placenta previa
Cervical cerclage
Abnormal fetal anatomy (in the opinion of the IoR or designee)
Intrauterine growth restriction
Pre-existing or gestational diabetes
Hypertensive disorder of pregnancy
Treatment for preterm labor
By participant mother report, or noted on review of medical record, any of the following in a previous pregnancy:
Intrauterine growth restriction
Gestational diabetes
Hypertensive disorder of pregnancy
Intrauterine fetal demise (estimated gestational age 20 weeks or greater)
Delivery prior to 37 0/7 weeks
By participant mother report at screening or enrollment:
Intends to relocate away from the study site during the period of expected study visits
Plans to travel away from the study site during the expected study product dosing period, such that travel would preclude the completion of one or more scheduled study visits
Plans to deliver outside of a hospital. More information on this criterion can be found in the protocol.
Currently breastfeeding
As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease, including active tuberculosis, or medication use that would make study participation unsafe. More information on this criterion can be found in the protocol.
At enrollment, clinically apparent Grade 2 or higher pelvic exam finding (observed by study staff). More information on this criterion can be found in the protocol.
Has any of the following laboratory abnormalities during the screening period:
Hemoglobin value of Grade 3 or higher according to Division of AIDS (DAIDS) Toxicity Table
Platelet count less than 100,000 mm^3
Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 times the upper limit of normal
Serum creatinine greater than 1.0 mg/dL
Hepatitis B surface antigen (HBsAg) positivity
Urine dipstick positive for protein greater than or equal to 2
Urine dipstick positive for glucose greater than or equal to 2
Positive for malaria (at sites with capacity, where women are at risk and testing through antenatal care provider is not otherwise available)
More information on this criterion can be found in the protocol
Grade 2 or higher Pap result (e.g., high-grade squamous intraepithelial lesion). More information on this criterion can be found in the protocol.
Diagnosed with a sexually transmitted infection or reproductive tract infection requiring treatment, per current Centers for Disease Control and Prevention (CDC) or World Health Organization (WHO) guidelines, as applicable. More information on this criterion can be found in the protocol.
Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

About this study

Official title: Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy

Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug tenofovir may reduce the risk of HIV infection in women when used near the time of sexual intercourse. This study will evaluate the safety of 1% tenofovir gel in HIV-uninfected pregnant women and their newborns when the gel is used once a day for a period of 28 days at a designated time during pregnancy.

Read the detailed description

Pregnant women often maintain sexual activity, and research has shown that they may have a greater risk of acquiring HIV infection during pregnancy. Preliminary research has suggested that tenofovir 1% gel, a vaginal microbicide, may reduce the risk of HIV infection for women when it is applied at the time of sexual intercourse. However, safety data on the use of tenofovir 1% gel during pregnancy are limited. This study will enroll pregnant women who will use tenofovir 1% gel on a daily basis for 28 consecutive days during their pregnancy, which is a longer period of use than has been studied previously. The purpose of this study is to evaluate the safety of 1% tenofovir gel in HIV-uninfected pregnant women when used during the late first trimester and second trimester of pregnancy.

Participants will be healthy, HIV-uninfected pregnant women and will be randomly assigned to use either 1% tenofovir gel or placebo gel once a day for 28 days or until delivery, whichever comes first. Participants will be further divided into four groups of varying gestational age ranges. These groups will be filled sequentially, starting with the later gestational ages (closer to the time of delivery) group first. Once the safety for this group is confirmed, groups of participants with earlier gestational ages will be enrolled.

Length of participation in this study will vary depending on gestational age at the time of enrollment, but each participant will have visits at study entry; Days 7, 14, and 28; 2 weeks after the last dose of the assigned gel; and once every 4 weeks until delivery. Participants who have used the gel within 24 hours of arriving at the hospital for delivery also will have a delivery visit. At most visits, participants will give a medical history; undergo blood and urine collection; and have a physical exam, including obstetric (OB) abdominal and pelvic exams. Participants also will report adverse events and complete an adherence assessment. If a participant has a delivery visit, blood will be collected from the umbilical cord and delivery and infant information will be collected. All participants will attend a follow-up study visit 30 days after delivery.

Conditions: HIV Infections
Being tested: 1% tenofovir gel, Placebo gel
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1% tenofovir gelDrug
One applicator of 1% tenofovir gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first
Placebo gelDrug
One applicator of placebo gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first

Study groups in NCT01490671
Study group	Role	What they receive
Group 1a (tenofovir gel)	Experimental	Group 1a will include women with a gestational age range of 36 0/7 to 37 6/7 weeks; they will receive 1% tenofovir gel Receives: Drug: 1% tenofovir gel
Group 1b (placebo gel)	Placebo comparator	Group 1b will include women with a gestational age range of 36 0/7 to 37 6/7 weeks; they will receive placebo gel. Receives: Drug: Placebo gel
Group 2a (tenofovir gel)	Experimental	Group 2a will include women with a gestational age range of 28 0/7 to 32 6/7 weeks; they will receive 1% tenofovir gel. Receives: Drug: 1% tenofovir gel
Group 2b (placebo gel)	Placebo comparator	Group 2b will include women with a gestational age range of 28 0/7 to 32 6/7 weeks; they will receive placebo gel. Receives: Drug: Placebo gel
Group 3a (tenofovir gel)	Experimental	Group 3a will include women with a gestational age range of 20 0/7 to 24 6/7 weeks; they will receive 1% tenofovir gel. Receives: Drug: 1% tenofovir gel
Group 3b (placebo gel)	Placebo comparator	Group 3b will include women with a gestational age range of 20 0/7 to 24 6/7 weeks; they will receive placebo gel. Receives: Drug: Placebo gel
Group 4a (tenofovir gel)	Experimental	Group 4a will include women with a gestational age range of 12 0/7 to 16 6/7 weeks; they will receive 1% tenofovir gel. Receives: Drug: 1% tenofovir gel
Group 4b (placebo gel)	Placebo comparator	Group 4b will include women with a gestational age range of 12 0/7 to 16 6/7 weeks; they will receive placebo gel. Receives: Drug: Placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal outcomes: Grade 2 or higher adverse events (AEs) in select categories
Categories include: specific laboratory abnormalities, specific genital/pelvic signs/symptoms, and pregnancy complications
Measured: Measured through participant's last study visit, which will occur 30 days after delivery
Neonatal outcomes (first 30 days of life): All serious adverse events (SAEs)
Measured: Measured through the 30 day follow-up visit

Secondary outcomes (4)

Pharmacokinetics of tenofovir in mothers
Blood samples will be collected pre- and post-tenfovoir dose to measure tenofovir levels and to estimate the maximum concentration (Cmax)
Measured: Measured at Day 14 visit
Self-reported product use captured through questionnaires
Measured: Measured through participant's last study visit, which will occur 30 days after delivery
Adherence to study gel as indicated by study drug levels in blood sample
Measured: Measured through participant's last study visit, which will occur 30 days after delivery
Adherence to study gel obtained by count of returned unused applicators
Measured: Measured through participant's last study visit, which will occur 30 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?Aug 2015

First posted13 Dec 2011 (estimated)
Primary completionAug 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490671
Sponsor's protocol ID: MTN-019
Other IDs: 11839
Status last verified: Oct 2021
First submitted: 8 Dec 2011
Last updated: 1 Nov 2021
Results posted: No
Data monitoring committee: Yes

Publications

Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.
PubMed 20643915
Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother. 2008 Nov;42(11):1581-5. doi: 10.1345/aph.1L083. Epub 2008 Oct 28.
PubMed 18957630

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy
ClinicalTrials.gov ID: NCT01490671
Acronym / sponsor ID: MTN-019
Conditions: HIV Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Primary completion: Aug 2015 (estimated)
First posted: 13 Dec 2011 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 8

Arm	Type	Receives
Group 1a (tenofovir gel)	Experimental	Drug: 1% tenofovir gelGroup 1a will include women with a gestational age range of 36 0/7 to 37 6/7 weeks; they will receive 1% tenofovir gel
Group 1b (placebo gel)	Placebo comparator	Drug: Placebo gelGroup 1b will include women with a gestational age range of 36 0/7 to 37 6/7 weeks; they will receive placebo gel.
Group 2a (tenofovir gel)	Experimental	Drug: 1% tenofovir gelGroup 2a will include women with a gestational age range of 28 0/7 to 32 6/7 weeks; they will receive 1% tenofovir gel.
Group 2b (placebo gel)	Placebo comparator	Drug: Placebo gelGroup 2b will include women with a gestational age range of 28 0/7 to 32 6/7 weeks; they will receive placebo gel.
Group 3a (tenofovir gel)	Experimental	Drug: 1% tenofovir gelGroup 3a will include women with a gestational age range of 20 0/7 to 24 6/7 weeks; they will receive 1% tenofovir gel.
Group 3b (placebo gel)	Placebo comparator	Drug: Placebo gelGroup 3b will include women with a gestational age range of 20 0/7 to 24 6/7 weeks; they will receive placebo gel.
Group 4a (tenofovir gel)	Experimental	Drug: 1% tenofovir gelGroup 4a will include women with a gestational age range of 12 0/7 to 16 6/7 weeks; they will receive 1% tenofovir gel.
Group 4b (placebo gel)	Placebo comparator	Drug: Placebo gelGroup 4b will include women with a gestational age range of 12 0/7 to 16 6/7 weeks; they will receive placebo gel.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Age 18 through 45 years (inclusive) at screening, verified per site standard operating procedures (SOPs)
At enrollment, singleton, viable pregnancy of gestational age within the limits for current group for enrollment
Per participant report, sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
Able and willing to provide the following:
HIV-uninfected based on testing performed by study staff at screening and enrollment (per algorithm in protocol)

Key exclusion criteria (41 listed)

Participant mother reported any of the following:
By participant mother report, noted on antenatal record, or clinical evidence at the time of enrollment of any of the following in the current pregnancy:
By participant mother report, or noted on review of medical record, any of the following in a previous pregnancy:
By participant mother report at screening or enrollment:
Currently breastfeeding

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
1% tenofovir gelOne applicator of 1% tenofovir gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first	Drug	Group 1a (tenofovir gel), Group 2a (tenofovir gel), Group 3a (tenofovir gel), Group 4a (tenofovir gel)
Placebo gelOne applicator of placebo gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first	Drug	Group 1b (placebo gel), Group 2b (placebo gel), Group 3b (placebo gel), Group 4b (placebo gel)

Primary outcome

Maternal outcomes: Grade 2 or higher adverse events (AEs) in select categories
Time frame: Measured through participant's last study visit, which will occur 30 days after delivery
Categories include: specific laboratory abnormalities, specific genital/pelvic signs/symptoms, and pregnancy complications
Neonatal outcomes (first 30 days of life): All serious adverse events (SAEs)
Time frame: Measured through the 30 day follow-up visit

4 secondary outcomes

Pharmacokinetics of tenofovir in mothers
Time frame: Measured at Day 14 visit
Self-reported product use captured through questionnaires
Time frame: Measured through participant's last study visit, which will occur 30 days after delivery
Adherence to study gel as indicated by study drug levels in blood sample
Time frame: Measured through participant's last study visit, which will occur 30 days after delivery
Adherence to study gel obtained by count of returned unused applicators
Time frame: Measured through participant's last study visit, which will occur 30 days after delivery

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Background: PubMed 20643915Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19.
Background: PubMed 18957630Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother. 2008 Nov;42(11):1581-5. doi: 10.1345/aph.1L083. Epub 2008 Oct 28.

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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 H Beigi, MD, MSc study chair

University of Pittsburgh

Bonus Makanani, MBBS, FCOG (SA) study chair

Kamuzu University of Health Sciences

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1% tenofovir gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 14 inclusion and 41 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: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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 outcomes: Grade 2 or higher adverse events (AEs) in select categories (time frame: Measured through participant's last study visit, which will occur 30 days after delivery). The study lists 2 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 NCT01490671, which also lists 2 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 1 Nov 2021.