HIVNCT01597180
Pharmacokinetics, Pharmacodynamics and Cervicovaginal Lavage of Combined Oral Contraceptives and Raltegravir
An observational study of HIV, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- HIV
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women recruited from an infectious diseases clinic in Chapel Hill, NC.
Who may be able to join
- Women between 20-40 years of age with regular monthly menses
- If over age 35 then must not use tobacco
- Negative pregnancy test
- No known allergy to raltegravir
- No known history of phenylketonuria
- Undetectable HIV viral load
Show all 19Show fewer
- No active liver disease as determined by medical history and normal AST and ALT
- No history of hepatic adenomas, carcinomas or benign liver tumors
- Ho history of thrombophlebitis of thromboembolic disease
- No history of deep vein thrombosis
- No history of cerebral vascular or coronary artery disease
- No known or suspected carcinoma of the breast
- No undiagnosed abnormal genital bleeding
- Not taking concomitant CYP 450 inducing medications such as anti-seizure medications
- No use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening
- No cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use
- Has used raltegravir prior to screening
- Has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer)
- Must not have had an abnormal pap test defined without resolution in the last 18 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Infectious Disease Clinic
Chapel Hill, North Carolina, 27516
About this study
Official title: Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir
The purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.
The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.
- Conditions
- HIV
- Keywords
- contraception, HIV, pharmacokinetics, pharmacodynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cervicovaginal fluide milieu
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Could not find subjects who met all the enrollment criteria so the study was stopped.
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 North Carolina, Chapel HillThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Gretchen Stuart, MD, University of North Carolina, Chapel Hill
- Investigators
- Gretchen S Stuart, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597180
- Sponsor's protocol ID
- 12-0832
- Status last verified
- Mar 2014
- First submitted
- 9 May 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir
- ClinicalTrials.gov ID
- NCT01597180
- Acronym / sponsor ID
- 12-0832
- Conditions
- HIV
- Keywords
- contraception, HIV, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Could not find subjects who met all the enrollment criteria so the study was stopped.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 May 2012 (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 purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in HIV+ women. The investigators plan to enroll HIV+ women who are on steady state raltegravir containing highly active antiretroviral therapy (HAART), ages 20-40, inclusive, who report regular monthly menses.
The investigators will investigate drug interactions of raltegravir, ethinyl estradiol (EE) and levonorgestrel (LNG). All women will be receiving raltegravir as part of their regular medical care. Women will be enrolled in the study for approximately 8 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women recruited from an infectious diseases clinic in Chapel Hill, NC.
Key inclusion criteria (19 listed)
- Women between 20-40 years of age with regular monthly menses
- If over age 35 then must not use tobacco
- Negative pregnancy test
- No known allergy to raltegravir
- No known history of phenylketonuria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in cervicovaginal fluide milieu
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 5 Mar 2014.
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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.
Gretchen S Stuart, MD principal investigator
University of North Carolina, Chapel Hill
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 North Carolina, Chapel Hill 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 19 inclusion and 0 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 5 Mar 2014. 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 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?
Change in cervicovaginal fluide milieu. 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 5 Mar 2014.