HIVNCT02375425
Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception
An observational study of HIV, run by University of Pittsburgh at 1 site in United States.
Trial summary
The development of surrogates to predict HIV prevention product safety and efficacy is a high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab showed significant reduction in HIV replication… 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
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- Phase
- Observational
- 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
Study population: non-pregnant, HIV negative, healthy 18-45 year old women
Who may be able to join
- Age 18-45
- HIV uninfected. Note: if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. Otherwise, the potential participant should undergo testing at the first study visit.
- Willing and able to give informed consent to take place in the study
- Willing to undergo a pelvic examination and genital biopsies and HIV and HSV testing
- Willing to provide contact information
- Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit
Who cannot join
- Menopausal
- Pregnant or within 90 days of last pregnancy
- Hysterectomy
- Use of a diaphragm, NuvaRing or spermicide for contraception
- Reports a course of antibiotic therapy in the 14 days prior to enrollment
- Known history of platelet disorder or bleeding disorder
Show all 11Show fewer
- Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
- Pelvic exam findings concerning for cervicitis including abnormal cervical discharge, erythema and edema
- Use of any spermicide or spermicide-lubricated condom within one week of enrollment.
- Use of any internal vaginal device or product with the exception of tampons within one week of enrollment
- Any other condition that in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of 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
About this study
The development of surrogates to predict HIV prevention product safety and efficacy is a high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab showed significant reduction in HIV replication when compared to tissue exposed to placebo gel. Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Currently the Reproductive Infectious Disease Research Group is conducting a study designed to answer important questions about the ex vivo challenge model:which HIV virus is the best to use in the laboratory and what is the best indicator of HIV infection. The proposed study delineated here will investigate the effect of BV, HSV and contraceptive use on the model . There will be two arms to the study; the first will investigate the impact of HSV and BV status and the second, contraceptive use. Vaginal and cervical biopsies will be collected from participants for the ex vivo challenge model.
- Conditions
- HIV
- Being tested
- no intervention
- Keywords
- BV, HSV, contraceptive, ex vivo challenge model
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention-specimen collection study only
| Study group | Role | What they receive |
|---|---|---|
| No contraceptive use | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ Receives: Other: no intervention | |
| levonorgestrel IUD | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ Receives: Other: no intervention | |
| paraguard IUD | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ Receives: Other: no intervention | |
| DMPA | BV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV infection of cervical and vaginal biopsies as measured by HIV-1 p24 replication by ELISA or by qPCR for HIV provirus
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Katherine Bunge, University of Pittsburgh
- Investigators
- Katherine Bunge, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375425
- Sponsor's protocol ID
- PRO14090571
- Status last verified
- Dec 2018
- First submitted
- 24 Feb 2015
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the ex Vivo Challenge: Reproductive Infections and Contraception
- ClinicalTrials.gov ID
- NCT02375425
- Acronym / sponsor ID
- PRO14090571
- Conditions
- HIV
- Keywords
- BV, HSV, contraceptive, ex vivo challenge model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Mar 2015 (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.
The development of surrogates to predict HIV prevention product safety and efficacy is a high priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed to rectally applied microbicides in vivo and then challenged with HIV in the lab showed significant reduction in HIV replication when compared to tissue exposed to placebo gel. Currently, the ex vivo challenge model for ectocervical and vaginal tissue is under development at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Currently the Reproductive Infectious Disease Research Group is conducting a study designed to answer important questions about the ex vivo challenge model:which HIV virus is the best to use in the laboratory and what is the best indicator of HIV infection. The proposed study delineated here will investigate the effect of BV, HSV and contraceptive use on the model . There will be two arms to the study; the first will investigate the impact of HSV and BV status and the second, contraceptive use. Vaginal and cervical biopsies will be collected from participants for the ex vivo challenge model.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No contraceptive use | – | Other: no interventionBV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| levonorgestrel IUD | – | Other: no interventionBV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| paraguard IUD | – | Other: no interventionBV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
| DMPA | – | Other: no interventionBV-/HSV- BV-/HSV+ BV+/HSV- BV+/HSV+ |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- non-pregnant, HIV negative, healthy 18-45 year old women
Key inclusion criteria (6 listed)
- Age 18-45
- HIV uninfected. Note: if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. Otherwise, the potential participant should undergo testing at the first study visit.
- Willing and able to give informed consent to take place in the study
- Willing to undergo a pelvic examination and genital biopsies and HIV and HSV testing
- Willing to provide contact information
Key exclusion criteria (11 listed)
- Menopausal
- Pregnant or within 90 days of last pregnancy
- Hysterectomy
- Use of a diaphragm, NuvaRing or spermicide for contraception
- Reports a course of antibiotic therapy in the 14 days prior to enrollment
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 |
|---|---|---|
| no interventionno intervention-specimen collection study only | Other | DMPA, No contraceptive use, levonorgestrel IUD, paraguard IUD |
Primary outcome
HIV infection of cervical and vaginal biopsies as measured by HIV-1 p24 replication by ELISA or by qPCR for HIV provirus
Time frame: baseline
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 24 Dec 2018.
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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.
Katherine Bunge, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Pittsburgh 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 6 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 24 Dec 2018. 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.
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?
HIV infection of cervical and vaginal biopsies as measured by HIV-1 p24 replication by ELISA or by qPCR for HIV provirus (time frame: baseline). 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 24 Dec 2018.