HIVMIPNCT02333045
Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women
A study testing Truvada qd and Maraviroc 300 qd in people with HIV, run by Emory University at 2 sites in United States.
Trial summary
This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Truvada qd and Maraviroc 300 qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 28 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-44 years
- Must be biologically female (defined as sex at birth)
- HIV negative women with at least one of the following risk factors in the past 5 years
- Injection drug use or use of crack, cocaine, heroin, or methamphetamine
- Diagnosed with a sexually transmitted infection
- Unprotected sex with 3 or more men
Show all 24Show fewer
- Having sex for drugs, money, or shelter
- Sex with a known HIV-positive man
- Having a partner meeting any of the preceding criteria
- Normal menses (within 22-35 day intervals) for at least 3 cycles
- No history of alcohol abuse, heart disease, or liver disease, or any other medical condition that would interfere with the conduct of the study, in the opinion of the study investigator
- No history of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery
- Normal chemistry, liver function, and complete blood count panels at screening, including:
- Absolute neutrophil count (ANC) ≥ 750/mm3
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 100,000/mm3
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 3 x Upper Limit Normal (ULN)
- Total bilirubin ≤ 2.5 x ULN
- Creatinine Clearance (CrCl) ≥ 60 mL/min as estimated by the Cockcroft-Gault equation
- Negative hepatitis B surface antigen (HBsAg)
- No signs or symptoms of orthostasis
- No signs or symptoms of vaginal infection or genital ulcer disease at screening or untreated vaginal infection in the last 30 days
- Not receiving concurrent medications that interact with maraviroc (MVC) or any antiretrovirals (such as tenofovir/ emtricitabine [Truvada®]) for the purpose of HIV prevention
- Willing to use condoms for the duration of the study and abstain from sexual intercourse for 48 hours before each genital tract sampling
Who cannot join
- Male sex (defined as sex at birth)
- Pregnant or breastfeeding
- Current use of systemic hormonal contraception
- Symptomatic vaginal infection or genital ulcer disease at screening or treatment for vaginal infection in the last two weeks
- Active malignancy for which the participant is undergoing evaluation and/or treatment
- Immunosuppressive medications (i.e, systemic steroids)
- Any surgery in the preceding 2 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Grady Infectious Diseases Clinic (Ponce Clinic)
Atlanta, Georgia, 30308
About this study
This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection.
Read the detailed description
In this study, the investigator seeks to understand the immune cells in the cervical fluid of HIV-negative healthy female volunteers, and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection. Maraviroc works by preventing HIV from entering human immune cells by blocking a protein on the outside of these cells called the C-C chemokine receptor type 5 (CCR5) receptor. When maraviroc is bound to this protein, the virus cannot enter the cell. The investigator thinks that CCR5 antagonists could be particularly good drugs for HIV pre-exposure prophylaxis (PrEP) and could potentially be dosed in ways that are easier to take than the current drugs used for PrEP.
In order to further evaluate this PrEP strategy, the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age, menstrual cycle, and genital infections.
The amount of maraviroc compared with the drugs in the current drugs used for PrEP (tenofovir/ emtricitabine) in the blood and genital tract of HIV-negative healthy female volunteers before, during, and after they are given maraviroc versus tenofovir/ emtricitabine for 7 days will be measured. We will also study immune cells from the blood and genital tract from these women to see if maraviroc, tenofovir, or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV.
- Conditions
- HIV
- Being tested
- Truvada qd, Maraviroc 300 qd
- Keywords
- HIV-negative, Women, At-risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truvada qdDrug
Also called Truvada
Truvada 1 tablet PO daily for 7 days
Maraviroc 300 qdDrug
Also called Selzentry
Maraviroc 300 mg PO daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Truvada qd | Experimental | Women will be assigned at random Truvada 1 tablet PO daily Receives: Drug: Truvada qd |
| Maraviroc 300 qd | Experimental | Women will be assigned at random Maraviroc 300 mg PO daily Receives: Drug: Maraviroc 300 qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Total Cells Obtained From Cervicovaginal Lavage Samples
The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.
Measured: Baseline, Day 7, Day 14, Day 21
Secondary outcomes (2)
Steady-state Area Under the Plasma Concentration-time Curve of Study Drug
Study drug concentrations will be measured from blood.
Measured: 7 days
Steady-state Area Under the Female Genital Tract Concentration-time Curve of Study Drug
Study drug concentrations will be measured from female genital tract.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion28 Oct 2016
- Study completion28 Oct 2016
Why it stopped: Minimal efficacy of maraviroc alone was found in preliminary data analysis of another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anandi Sheth, Emory University
- Investigators
- Anandi Sheth, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333045
- Sponsor's protocol ID
- IRB00074767
- Acronym
- MIP
- Status last verified
- Dec 2017
- First submitted
- 5 Jan 2015
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women
- ClinicalTrials.gov ID
- NCT02333045
- Acronym / sponsor ID
- MIP / IRB00074767
- Conditions
- HIV
- Keywords
- HIV-negative, Women, At-risk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Minimal efficacy of maraviroc alone was found in preliminary data analysis of another study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection.
Detailed description
In this study, the investigator seeks to understand the immune cells in the cervical fluid of HIV-negative healthy female volunteers, and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection. Maraviroc works by preventing HIV from entering human immune cells by blocking a protein on the outside of these cells called the C-C chemokine receptor type 5 (CCR5) receptor. When maraviroc is bound to this protein, the virus cannot enter the cell. The investigator thinks that CCR5 antagonists could be particularly good drugs for HIV pre-exposure prophylaxis (PrEP) and could potentially be dosed in ways that are easier to take than the current drugs used for PrEP.
In order to further evaluate this PrEP strategy, the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age, menstrual cycle, and genital infections.
The amount of maraviroc compared with the drugs in the current drugs used for PrEP (tenofovir/ emtricitabine) in the blood and genital tract of HIV-negative healthy female volunteers before, during, and after they are given maraviroc versus tenofovir/ emtricitabine for 7 days will be measured. We will also study immune cells from the blood and genital tract from these women to see if maraviroc, tenofovir, or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truvada qd | Experimental | Drug: Truvada qdWomen will be assigned at random Truvada 1 tablet PO daily |
| Maraviroc 300 qd | Experimental | Drug: Maraviroc 300 qdWomen will be assigned at random Maraviroc 300 mg PO daily |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Age 18-44 years
- Must be biologically female (defined as sex at birth)
- HIV negative women with at least one of the following risk factors in the past 5 years
- Normal menses (within 22-35 day intervals) for at least 3 cycles
- No history of alcohol abuse, heart disease, or liver disease, or any other medical condition that would interfere with the conduct of the study, in the opinion of the study investigator
Key exclusion criteria (7 listed)
- Male sex (defined as sex at birth)
- Pregnant or breastfeeding
- Current use of systemic hormonal contraception
- Symptomatic vaginal infection or genital ulcer disease at screening or treatment for vaginal infection in the last two weeks
- Active malignancy for which the participant is undergoing evaluation and/or treatment
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 |
|---|---|---|
| Truvada qdAlso: TruvadaTruvada 1 tablet PO daily for 7 days | Drug | Truvada qd |
| Maraviroc 300 qdAlso: SelzentryMaraviroc 300 mg PO daily for 7 days | Drug | Maraviroc 300 qd |
Primary outcome
Count of Total Cells Obtained From Cervicovaginal Lavage Samples
Time frame: Baseline, Day 7, Day 14, Day 21
The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.
2 secondary outcomes
Steady-state Area Under the Plasma Concentration-time Curve of Study Drug
Time frame: 7 days
Steady-state Area Under the Female Genital Tract Concentration-time Curve of Study Drug
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anandi Sheth, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truvada qd and Maraviroc 300 qd in people with HIV, run by Emory University at 2 sites 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 24 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Total Cells Obtained From Cervicovaginal Lavage Samples (time frame: Baseline, Day 7, Day 14, Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2018.