HIV InfectionsPhase 1NCT00399685
Drug Interaction - Oral Contraceptive
A Phase 1 study testing Ortho Tri-Cyclen LO, Ortho Cyclen and Ortho Cyclen + Efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied. 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
- What is being tested?
- Ortho Tri-Cyclen LO, Ortho Cyclen and Ortho Cyclen + Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Aug 2007
- 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
- Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
- Documented acceptable Pap smear within 1 year of the start of the study
- BMI of 18-32 kg/m²
Who cannot join
- Males
- Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
- History of conditions in which oral contraceptives are contraindicated
- History of migraine with focal aura
- History of uncontrolled hypertension
- Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
- History of diagnosed mental illness or suicidal ideation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Covance Clinical Research Unit San Diego
San Diego, California, 92123
Northwest Kinetics
Tacoma, Washington, 98418
About this study
Official title: Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.
- Conditions
- HIV Infections
- Being tested
- Ortho Tri-Cyclen LO, Ortho Cyclen, Ortho Cyclen + Efavirenz
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho Tri-Cyclen LODrug
Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.
Ortho CyclenDrug
Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.
Ortho Cyclen + EfavirenzDrug
Also called Sustiva
Tablet, oral, OC + EFV 600 mg, once daily, 14 days.
Ortho CyclenDrug
Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Ortho Tri-Cyclen LO |
| B | Active comparator | Not described Receives: Drug: Ortho Cyclen |
| C | Active comparator | Not described Receives: Drug: Ortho Cyclen + Efavirenz |
| D | Active comparator | Not described Receives: Drug: Ortho Cyclen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
Measured: throughout the study
Secondary outcomes (3)
Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
Measured: throughout the study
Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
Measured: throughout the study
Assess the safety of efavirenz coadministered with Ortho Cyclen
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionAug 2007
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 Bristol-Myers SquibbThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399685
- Sponsor's protocol ID
- AI266-145
- Status last verified
- Apr 2011
- First submitted
- 14 Nov 2006
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00399685
- Acronym / sponsor ID
- AI266-145
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Nov 2006 (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 administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Ortho Tri-Cyclen LO |
| B | Active comparator | Drug: Ortho Cyclen |
| C | Active comparator | Drug: Ortho Cyclen + Efavirenz |
| D | Active comparator | Drug: Ortho Cyclen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
- Documented acceptable Pap smear within 1 year of the start of the study
- BMI of 18-32 kg/m²
Key exclusion criteria (7 listed)
- Males
- Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
- History of conditions in which oral contraceptives are contraindicated
- History of migraine with focal aura
- History of uncontrolled hypertension
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 |
|---|---|---|
| Ortho Tri-Cyclen LOTablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days. | Drug | A |
| Ortho CyclenTablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days. | Drug | B |
| Ortho Cyclen + EfavirenzAlso: SustivaTablet, oral, OC + EFV 600 mg, once daily, 14 days. | Drug | C |
| Ortho CyclenTablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days. | Drug | D |
Primary outcome
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
Time frame: throughout the study
3 secondary outcomes
Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen
Time frame: throughout the study
Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels
Time frame: throughout the study
Assess the safety of efavirenz coadministered with Ortho Cyclen
Time frame: throughout the 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 14 Apr 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Ortho Tri-Cyclen LO, Ortho Cyclen and Ortho Cyclen + Efavirenz in people with HIV Infections, run by Bristol-Myers Squibb 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 3 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 14 Apr 2011. 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?
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate (time frame: throughout the 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 14 Apr 2011; AzTrials last refreshed its copy on 31 Oct 2026.