Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel

NCT01768962 | Completed Phase 1 DMC

• 3 other identifiers: MTN-0145UM1AI06863311885
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

Conditions

HIV Prevention

Keywords

Microbicides; Tenofovir; Reduced-glycerin; Vaginal use; Rectal use; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Drug concentrations

  To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

  10 weeks

Secondary Outcomes (1)

• Number of adverse events Grade 2 or higher

  10 weeks

Other Outcomes (2)

• Inhibition of HIV by study drug in rectal and genital fluids

  10 weeks

• Microflora biomarkers and gene expression from the vaginal and rectal environments

  10 weeks

Study Arms (2)

Sequence A

ACTIVE COMPARATOR

2 weeks, 6 week washout, 2 weeks

Drug: Once Daily Application of TFV RG 1% Gel - Vaginal; Drug: Once Daily Application of TFV RG 1% gel - Rectal

Sequence B

ACTIVE COMPARATOR

2 weeks, 6 week washout, 2 weeks

Drug: Once Daily Application of TFV RG 1% gel - Rectal; Drug: Once Daily Application of TFV RG 1% Gel - Vaginal

Interventions

Once Daily Application of TFV RG 1% Gel - Vaginal DRUG

Vaginal application

Sequence A

Once Daily Application of TFV RG 1% gel - Rectal DRUG

Rectal application

Sequence A

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21 through 45 years (inclusive) at Screening
• Able and willing to provide written informed consent
• Able and willing to comply with all study procedure requirements, including, clinical and laboratory assessments, vaginal and rectal examinations, urine and blood testing, as well as attendance at all scheduled study visits
• In general good health at Screening and Enrollment as determined by the Investigator of Record (IoR)/ or designee
• Negative pregnancy test at Screening and Enrollment
• HIV-negative at Screening and Enrollment
• Able and willing to provide adequate locator information
• Willingness to use study-provided male condoms for the duration of study participation for penetrative intercourse
• Per participant report at Screening, regular menstrual cycles with at least 21 days between menses (does not apply to participants who report using a progestin-only method of contraception at screening, e.g., Depo-Provera, progesterone-containing IUDs or extended use of oral contraceptives)
• Per participant report at Enrollment, using an effective method of contraception and intending to use an effective method for the duration of study participation; effective methods include:
• Hormonal methods, excluding vaginal rings
• Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions)
• Sterilization of participant or partner at least 42 days prior to Enrollment
• Self-identifies as a woman who has sex with women exclusively
• Sexually abstinent for the at least 90 days prior to enrollment and the intention to remain sexually abstinent for the duration of study participation

You may not qualify if:

• Participant report of any of the following:
• Known adverse reaction to the study product (ever)
• Known adverse reaction to latex (ever)
• Current male sex partner with known history of adverse reaction to latex (ever)
• History of serum HBsAg positivity (ever)
• Non-therapeutic injection drug use in the 12 calendar months prior to Enrollment
• Sexually transmitted infections (STI) or reproductive tract infection (RTI) requiring treatment in the 6 calendar months prior to Enrollment
• Post-exposure prophylaxis (PEP) for possible HIV-1 infection within the 6 calendar months prior to Enrollment
• Last pregnancy outcome within 90 days or less prior to Enrollment
• Participation in any other research study involving drugs, medical devices or vaginal products 42 days or less prior to Enrollment
• Anticipated IUD replacement within the next 3 months or an IUD inserted 42 days or less prior to Enrollment
• Participant report at Screening and/or Enrollment intention of becoming pregnant in the next 3 months
• Currently breastfeeding at the time of Screening and/or Enrollment
• History of bleeding problems (Participants in the biopsy subset only)
• Laboratory abnormalities at Screening greater than or equal to a Grade 2\*:

Sponsors & Collaborators

• CONRAD: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Infectious Disease Epidemiologic Research, Mailman School of Public Health, Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Justman JE, Nair GL, Hendrix CW, Piper JM, Marzinke MA, Dai JY, Pan Z, Galaska B, Levy L, Schwartz JL, Balar B, Kunjara Na Ayudhya RP, Mushamiri I, McGowan I, Dezzutti CS; MTN-014 Study Team. Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing. J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):175-182. doi: 10.1097/QAI.0000000000001655.

  PMID: 29767639 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Gonasagrie Nair, MBChB

  Centre for the AIDS Programme of Research in South Africa (CAPRISA) - eThekwini CRS

  STUDY CHAIR

• Jessica Justman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: January 16, 2013
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

US (1)