Unintended PregnancyCOCARVPKNCT00998725
Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi
An observational study of Unintended Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure… Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unintended Pregnancy
- How many people
- 0 participants
- Where
- 1 siteMalawi
- Study dates
- Nov 2009to Jan 2011
- 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 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 9 women with known HIV status who have regular monthly menses.
Who may be able to join
- Can provide informed consent
- Women ages 21-35 with known HIV status
- If HIV negative must have had an HIV test within the last 3 months
- Intend to stay in Lilongwe region for the duration of the study
- Desire to prevent pregnancy for at least the next six months
- Desires to use LoFemenal for contraception
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- Has no known history of infertility
- Has intact uterus and at least one ovary
- Has regular monthly menses defined by menses occurring every 21-35 days
- Has not used another form of systemic hormonal contraception within the last six months.
- Has no contraindications to the combined oral contraceptive LoFemenal which include; any thrombophlebitis or thromboembolic disorders; cerebral-vascular or coronary-artery disease (current or history); thrombogenic valvulopathies; thrombogenic rhythm disorders; major surgery with prolonged immobilization; diabetes with vascular involvement; headaches with focal neurological symptoms; uncontrolled hypertension; known or suspected carcinoma of the breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas or active lever disease, as long as liver function has not returned to normal; known or suspected pregnancy.
Who cannot join
- Hemoglobin < 10 mg/dL.
- Body mass index < 18.6 kg/m^2.
- Using any drugs known to interfere with cytochrome P450 system (such as rifampicin, phenytoin, carbamezapine, among others)
- In the opinion of the PI or study staff the individual cannot complete the study
- Cannot be adherent to other medications.
- Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:
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- Must be on antiretroviral therapy which includes nevirapine for at least three consecutive months immediately prior to enrollment into the study
- Must report adherence to medication and medical visits
- Must be willing to use a barrier or backup method of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.
- Conditions
- Unintended Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ARV+ | Not described | |
| HIV+ARV- | Not described | |
| HIV negative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who complete the study
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unintended PregnancyStudies 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, MPHTM, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998725
- Sponsor's protocol ID
- 08-1500
- Other IDs
- AI050410 (#9p30)
- Acronym
- COCARVPK
- Status last verified
- Feb 2017
- First submitted
- 16 Oct 2009
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pharmacokinetic and Pharmacodynamic Activity of LoFemenal
- ClinicalTrials.gov ID
- NCT00998725
- Acronym / sponsor ID
- COCARVPK / 08-1500
- Conditions
- Unintended Pregnancy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Oct 2009 (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 research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV+ARV+ | – | – |
| HIV+ARV- | – | – |
| HIV negative | – | – |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 9 women with known HIV status who have regular monthly menses.
Key inclusion criteria (11 listed)
- Can provide informed consent
- Women ages 21-35 with known HIV status
- If HIV negative must have had an HIV test within the last 3 months
- Intend to stay in Lilongwe region for the duration of the study
- Desire to prevent pregnancy for at least the next six months
Key exclusion criteria (9 listed)
- Hemoglobin < 10 mg/dL.
- Body mass index < 18.6 kg/m^2.
- Using any drugs known to interfere with cytochrome P450 system (such as rifampicin, phenytoin, carbamezapine, among others)
- In the opinion of the PI or study staff the individual cannot complete the study
- Cannot be adherent to other medications.
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
Number of women who complete the study
Time frame: 4 months
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 17 Feb 2017.
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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, MPHTM principal investigator
University of North Carolina
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 Unintended Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 11 inclusion and 9 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 17 Feb 2017. 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 Malawi. 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?
Number of women who complete the study (time frame: 4 months). 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 17 Feb 2017.