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HIV/AIDSEarly Phase 1DynamoPrEPNCT03197961

Pharmacokinetics and Pharmacodynamics of DMPA With HIV PrEP

A Early Phase 1 study testing tenofovir/emtricitabine and DMPA in people with HIV/AIDS and Contraception, run by Sharon Achilles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA. 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/AIDS, Contraception
What is being tested?
tenofovir/emtricitabine and DMPA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
17 Nov 2017to 1 Dec 2020
Phase
Early 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

  • Women aged 18-45 at screening
  • In general good health and without any clinically significant systemic disease by history and per investigator judgement
  • HIV negative at screening
  • Heterosexually abstinent, consistent use of condoms, or female or male partner sterilization
  • Currently having regular menstrual cycles (defined as cycles lasting 21-35 days by participant report)
  • Agree not to participate in any other clinical trials involving drugs or medical devices during the study period
  • Willing to comply with the study protocol

Who cannot join

  • Currently or recently pregnant or breastfeeding (defined as pregnancy or breastfeeding in the last 3 months)
  • Desiring pregnancy in the next 9 months
  • Use of copper intrauterine device or other method of hormonal contraception
  • Status post hysterectomy and/or bilateral oophorectomy
  • Positive test for Hepatitis B surface antigen at screening
  • Positive for Neisseria gonorrhea, Chlamydia trachomatis, or Trichomonas vaginalis at screening
Show all 18Show fewer
  • Positive syphilis screening test at screening
  • Symptomatic bacterial vaginosis, defined as vaginal symptoms with Nugent score ≥ 7. (If symptomatic bacterial vaginosis is treated at screening and asymptomatic at enrollment, the participant may enroll.)
  • Renal impairment (defined as creatinine clearance <60 ml/minute)
  • Known bleeding disorder
  • Daily use of NSAIDs
  • Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants, antifungals, antivirals, antiretrovirals, or other drugs known to prolong bleeding and/or clotting,
  • Use of DMPA in the 6 months prior to screening
  • Use of other hormonal contraception (including any contraceptive pill, patch, ring, implant, or levonorgestrel intrauterine device) in the 28 days prior to screening.
  • Surgery requiring inpatient admission, or any abdominal surgery <30 days prior to enrollment
  • Recreational or non-medical injection drug use in the 12 months prior to screening
  • In a sexual relationship with a partner known to be HIV-positive or at high-risk of HIV (e.g. known recreational injection drug user, incarcerated in the 12 months prior to screening, etc.)
  • Has any other condition that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, or complicate the interpretation of the study outcome data, or otherwise interfere with achieving the study objectives

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: The Pharmacokinetic and Pharmacodynamic Impacts of Depot Medroxyprogesterone Acetate on HIV Pre-exposure Prophylaxis (PrEP)

This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women aged 18-45 who are HIV-negative and at low risk for acquiring HIV.

Read the detailed description

The investigators hypothesize that a drug interaction exists between DMPA and tenofovir/emtricitabine, such that levels of tenofovir (TFV) and emtricitabine (FTC) in cervicovaginal fluid, rectal fluid, and blood plasma, and levels of the active metabolites of TFV and FTC in cervical tissue and peripheral blood mononuclear cells will be significantly lower when women are using DMPA than when they are using no hormonal contraception. The investigators secondarily hypothesize that ex vivo HIV replication will be less suppressed in cervical tissue and cervicovaginal fluid when women are using the co-formulated pre-exposure prophylaxis oral pill containing tenofovir disoproxil fumarate (TDF), the prodrug of tenofovir, and FTC concurrently with the contraceptive injection DMPA as compared to when they are on TDF/FTC alone. This study is a biphasic steady state pharmacokinetic and pharmacodynamic study of TFV and FTC in healthy women comparing the drug levels and activity in the absence (first phase) and then the presence (second phase) of DMPA. The investigators will recruit 12 healthy women aged 18-45 who are HIV-negative and at low risk for acquiring HIV. Participants will take TDF/FTC for 14 days, after which drug levels will be measured and DMPA administered. After at least a 2 week washout period for TDF/FTC, participants will again take TDF/FTC for 14 days, and drug levels will be measured again. HIV replication activity will also be measured in cervicovaginal fluid and cervical tissue at baseline before starting TDF/FTC, after 14 days of TDF/FTC, and then after the second 14 days of TDF/FTC in the presence of DMPA.

Being tested
tenofovir/emtricitabine, DMPA
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • tenofovir/emtricitabineCombination product

    Also called Truvada®

    At the enrollment visit, participants will be given a 14-day supply of tenofovir/emtricitabine 200mg/300mg to take once daily for 14 days. Drug concentrations will be measured as outlined in the outcomes section at the end of the two week period. The tenofovir/emtricitabine 200mg/300mg course will be repeated approximately 2 to 6 weeks later to allow washout of tenofovir/emtricitabine.

  • DMPADrug

    Also called Depot-Medroxyprogestereone Acetate

    After completion of the first 14 day course of tenofovir/emtricitabine depot medroxyprogesterone acetate 150 mg will be administered as intramuscular injection.

Study groups in NCT03197961
Study groupRoleWhat they receive
DMPA with tenofovir/emtricitabine PrEPExperimentalthe drug combination of tenofovir disoproxil fumarate 300mg and emtricitabine 200mg which is known as Truvada® will be taken orally once daily for 14 days by all participants. Drug concentrations will be measured (blood sampling) and one dose of Depot medroxyprogesterone acetate (DMPA) 150mg will be administered to each participant as an intramuscular injection after the first course of tenofovir disoproxil fumarate/emtricitabine is completed. Then, a second round of the combination of tenofovir disoproxil fumarate 300mg and emtricitabine 200mg (Truvada®) will be taken orally once daily for 14 days by all participants.
Receives: Combination Product: tenofovir/emtricitabine; Drug: DMPA

What is being measured

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

  1. Tenofovir and emtricitabine levels in the female genital tract, blood, and rectum

    The concentrations of tenofovir and emtricitabine in plasma, cervicovaginal fluid, and rectal fluid will be compared in women who are concomitantly using tenofovir/emtricitabine and DMPA as compared to using tenofovir/emtricitabine alone.

    Measured: Two weeks after daily dosing of tenofovir/emtricitabine; before and after administration of depot medroxyprogesterone acetate

Secondary outcomes (1)

  1. Ex vivo HIV replication in cervical tissue and cervicovaginal fluid

    Ex vivo HIV replication in cervical tissue and cervicovaginal fluid will be compared in women who are concomitantly using tenofovir/emtricitabine and DMPA as compared to using tenofovir/emtricitabine alone

    Measured: Before tenofovir/emtricitabine and two weeks after daily dosing of tenofovir/emtricitabine both before and after administration of depot medroxyprogesterone acetate

Timeline

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

  1. First posted23 Jun 2017
  2. Study start17 Nov 2017
  3. Primary completion18 Apr 2018
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
This is a biphasic steady state pharmacokinetic and pharmacodynamic study of healthy women to evaluate the concentrations and activity of tenofovir and emtricitabine in different compartments before and after the administration of DMPA. Each participant will receive the study medications in the same order, i.e. TDF/FTC alone for 14 days followed by TDF/FTC for 14 days after having received DMPA.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197961
Sponsor's protocol ID
PRO17010089
Acronym
DynamoPrEP
Status last verified
Dec 2020
First submitted
21 Jun 2017
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing tenofovir/emtricitabine and DMPA in people with HIV/AIDS and Contraception, run by Sharon Achilles 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 18 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 3 Dec 2020. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Tenofovir and emtricitabine levels in the female genital tract, blood, and rectum (time frame: Two weeks after daily dosing of tenofovir/emtricitabine; before and after administration of depot medroxyprogesterone acetate). 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 NCT03197961.

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 3 Dec 2020.

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