HIV InfectionsPhase 1NCT00482963
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
A Phase 1 study testing levonorgestrel, efavirenz in people with HIV Infections and Contraception, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz. 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 Infections, Contraception, Pharmacokinetics
- What is being tested?
- levonorgestrel, efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Dec 2008
- Phase
- 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
- Healthy, HIV-1 seronegative women of child-bearing age.
Who cannot join
- Current use of hormonal contraception
- Pregnancy/Breast Feeding
- Post-menopausal status
- Obesity
- Hepatitis B or C
- Psychiatric illness
- Active Substance Abuse
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Health Sciences Center
Denver, Colorado, 80262
The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.
Read the detailed description
The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.
- Conditions
- HIV Infections, Contraception, Pharmacokinetics
- Being tested
- levonorgestrel, efavirenz
- Keywords
- HIV, Contraception, Antiretroviral agents, Pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel, efavirenzDrug
| Study group | Role | What they receive |
|---|---|---|
| levonorgestrel, efavirenz | Experimental | healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz Receives: Drug: levonorgestrel, efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
Measured: 12 hour pharmacokinetic study
Secondary outcomes (4)
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Measured: 12 hour pharmacokinetic study
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Measured: 3 weeks
Changes in liver function tests before and during efavirenz
Measured: 3 weeks
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Measured: 12 hour pharmacokinetic study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, University of Washington, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Monica L Carten, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482963
- Sponsor's protocol ID
- 06-1178
- Status last verified
- Jul 2013
- First submitted
- 5 Jun 2007
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
- ClinicalTrials.gov ID
- NCT00482963
- Acronym / sponsor ID
- 06-1178
- Conditions
- HIV Infections, Contraception, Pharmacokinetics
- Keywords
- HIV, Contraception, Antiretroviral agents, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Miriam Hospital, University of Washington, Bristol-Myers Squibb
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Jun 2007 (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 study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.
Detailed description
The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| levonorgestrel, efavirenz | Experimental | Drug: levonorgestrel, efavirenzhealthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, HIV-1 seronegative women of child-bearing age.
Key exclusion criteria (7 listed)
- Current use of hormonal contraception
- Pregnancy/Breast Feeding
- Post-menopausal status
- Obesity
- Hepatitis B or C
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 |
|---|---|---|
| levonorgestrel, efavirenz | Drug | levonorgestrel, efavirenz |
Primary outcome
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
Time frame: 12 hour pharmacokinetic study
4 secondary outcomes
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Time frame: 12 hour pharmacokinetic study
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Time frame: 3 weeks
Changes in liver function tests before and during efavirenz
Time frame: 3 weeks
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Time frame: 12 hour pharmacokinetic study
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 15 Jul 2013.
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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.
Monica L Carten, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing levonorgestrel, efavirenz in people with HIV Infections and Contraception, run by University of Colorado, Denver 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 1 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: finished, as of the sponsor's last update on 15 Jul 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz (time frame: 12 hour pharmacokinetic study). 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 15 Jul 2013.