HIVPhase 1NCT02697851
Pharmacokinetic Effect of Evotaz/Microgynon Co-administration
A Phase 1 study testing Microgynon 30® and Evotaz® in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial summary
This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Microgynon 30® and Evotaz®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to 31 Oct 2017
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Non-pregnant, non-lactating females.
- Between 18 to 35 years, inclusive
- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
- ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
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- Women of childbearing potential (WOCBP) must be using an additional adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 4 weeks after the study (these include only the ones listed below, as no other hormone-based contraception is allowed during the study)
- A female may be eligible to enter and participate in the study if she:
- is of non-child-bearing potential defined as physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- is of child-bearing potential with a reliable negative pregnancy test at both Screening and Day 1 with no risk in between and agrees to use one of the following methods of contraception to avoid pregnancy from screening, throughout the study, and for at least 4 weeks after discontinuation of all study medications:
- Complete abstinence from penile-vaginal intercourse
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (please note that not all IUDs meet this criterion)
- Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
- Any other method with published data showing that the expected failure rate is <1% per year and not containing hormones.
- Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP.
- Willing to consent to their personal details being entered onto the TOPS database
- Willing to provide proof of identity by photographic ID at screen and any subsequent visit
- Registered with a GP in the UK
Who cannot join
- Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
- Any clinically significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Positive blood screen for hepatitis B surface antigen or C antibody
- Positive blood screen for HIV-1 or 2 by antibody/antigen assay
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
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- Any medical contra-indication to the use of combined oral contraceptives.
- History or presence of allergy to oral contraceptives, atazanavir and cobicistat or excipients (sodium methyl parahydroxybenzoate, lactulose, Hypromellose Colloidal silicon dioxide, Silicified microcrystalline cellulose Crospovidone, Magnesium stearate, Polyvinyl alcohol- partially hydrolysed, Macrogol 3350,Titanium dioxide, Talc, Iron oxide red, Iron oxide black, Lactose monohydrate, Magnesium stearate, Gelatine Yellow iron oxide, Indigocarmin (E132), White ink, Shellac,Titanium dioxide (E171), Ammonium hydroxide, Propylene glycol , Simethicone, Hypromellose, Polyvinyl alcohol- partially hydrolysed, Macrogol 3350)
- Current or recent (within three months) gastrointestinal disease
- Known intolerance of lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
- Exposure to any investigational drug (or placebo) or participation in a clinical study involving the donation of blood samples within three months of first dose of study drug
- Use of any medical products containing estrogens and/or progesteron, including IUS, implants etc. for 4 weeks before screening
- Use of any other drugs (unless approved by the Investigator), including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs
- Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least four weeks after the end of the treatment period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
About this study
Official title: The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women
This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders:
GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
Read the detailed description
Protocol Number: SSAT069
EudraCT Number: 2015-004799-30
Name of Investigational Product: Microgynon 30®; Evotaz®
Name of active ingredients: Ethinylestradiol, levonorgestrel; atazanavir, cobicistat
Study title: The effect of atazanavir/cobicistat on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (Microgynon 30®) in healthy women
Phase of study: Phase I
Objectives: The objectives of this study are:
Primary
-To assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary
- To assess the safety and tolerability of ethinylestradiol/levonorgestrel and atazanavir/cobicistat when co-administered to HIV negative female healthy volunteers
- To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 57 days (excluding screening and follow up), open label, cross-over, pharmacokinetic study
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Planned sample size: Up to 30 female healthy volunteers will be enrolled at baseline in order to achieve 18 completing the study
Summary of eligibility criteria: Healthy female participants as determined by medical history, physical examination, 12-lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. Women of childbearing potential must not be nursing or pregnant. Women of childbearing potential must have a negative pregnancy test at screening.
Number of study centres: One
Duration of treatment: 57 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Microgynon 30® (ethinylestradiol/levonorgestrel 30 micrograms/150 micrograms) and Evotaz® (atazanavir 300 mg/cobicistat 150 mg) as follows:
GROUP 1:
Microgynon 30® for 21 days Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Evotaz® for 14 days
GROUP 2:
Evotaz® for 14 days followed by 7 days wash-out Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack)
Criteria for evaluation: Pharmacokinetic parameters of ethinylestradiol/levonorgestrel and atazanavir/cobicistat will be evaluated on blood drawn on day 14, 35 and 56 at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24 hours post dose
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
Primary Endpoint: Steady state plasma concentrations of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary End point: Safety and tolerability of the studied drugs during co-administration
Relationship between genetic polymorphisms and exposure to the studied drugs
- Conditions
- HIV
- Being tested
- Microgynon 30®, Evotaz®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microgynon 30®Drug
Also called Ethinylestradiol/levonorgestrel
Evotaz®Drug
Also called Atazanavir /cobicistat
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days Receives: Drug: Microgynon 30®; Drug: Evotaz® |
| Group 2 | Experimental | Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56 Receives: Drug: Microgynon 30®; Drug: Evotaz® |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Cthrough
Trough concentration (Ctrough) is defined as the concentration at 24 hours after the observed drug dose
Measured: 26 to 36 weeks
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Cmax
Cmax defined as the maximum observed plasma concentration.
Measured: 26 to 36 weeks
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by t1/2
t1/2 = Elimination half-life
Measured: 26 to 36 weeks
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Tmax
Tmax = time point at Cmax
Measured: 26 to 36 weeks
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by total drug exposure
Total drug exposure is expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h)
Measured: 26 to 36 weeks
Secondary outcomes (4)
assess the safety and tolerability of the studied drug when co-administered to HIV negative female healthy volunteers, assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
studied drug: ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Measured: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by Peak plasma concentration (Cmax)
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Measured: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by trough concentration (Ctrough)
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Measured: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by Area under the plasma concentration versus time curve (AUC)
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Measured: 26 to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJul 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Why it stopped: Insufficient enrolment and "business reasons"
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Principal investigator, St Stephen's AIDS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697851
- Sponsor's protocol ID
- SSAT069
- Status last verified
- Dec 2017
- First submitted
- 2 Feb 2016
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women
- ClinicalTrials.gov ID
- NCT02697851
- Acronym / sponsor ID
- SSAT069
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrolment and "business reasons"
- Enrolment
- 13 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2016
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 3 Mar 2016 (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.
This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders:
GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
Detailed description
Protocol Number: SSAT069
EudraCT Number: 2015-004799-30
Name of Investigational Product: Microgynon 30®; Evotaz®
Name of active ingredients: Ethinylestradiol, levonorgestrel; atazanavir, cobicistat
Study title: The effect of atazanavir/cobicistat on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (Microgynon 30®) in healthy women
Phase of study: Phase I
Objectives: The objectives of this study are:
Primary
-To assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary
- To assess the safety and tolerability of ethinylestradiol/levonorgestrel and atazanavir/cobicistat when co-administered to HIV negative female healthy volunteers
- To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 57 days (excluding screening and follow up), open label, cross-over, pharmacokinetic study
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Planned sample size: Up to 30 female healthy volunteers will be enrolled at baseline in order to achieve 18 completing the study
Summary of eligibility criteria: Healthy female participants as determined by medical history, physical examination, 12-lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. Women of childbearing potential must not be nursing or pregnant. Women of childbearing potential must have a negative pregnancy test at screening.
Number of study centres: One
Duration of treatment: 57 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Microgynon 30® (ethinylestradiol/levonorgestrel 30 micrograms/150 micrograms) and Evotaz® (atazanavir 300 mg/cobicistat 150 mg) as follows:
GROUP 1:
Microgynon 30® for 21 days Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Evotaz® for 14 days
GROUP 2:
Evotaz® for 14 days followed by 7 days wash-out Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack)
Criteria for evaluation: Pharmacokinetic parameters of ethinylestradiol/levonorgestrel and atazanavir/cobicistat will be evaluated on blood drawn on day 14, 35 and 56 at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24 hours post dose
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
Primary Endpoint: Steady state plasma concentrations of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary End point: Safety and tolerability of the studied drugs during co-administration
Relationship between genetic polymorphisms and exposure to the studied drugs
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Microgynon 30®, Drug: Evotaz®Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days |
| Group 2 | Experimental | Drug: Microgynon 30®, Drug: Evotaz®Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Participants must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
- Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP.
Key exclusion criteria (15 listed)
- Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
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 |
|---|---|---|
| Microgynon 30®Also: Ethinylestradiol/levonorgestrel | Drug | Group 1, Group 2 |
| Evotaz®Also: Atazanavir /cobicistat | Drug | Group 1, Group 2 |
Primary outcome
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Cthrough
Time frame: 26 to 36 weeks
Trough concentration (Ctrough) is defined as the concentration at 24 hours after the observed drug dose
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Cmax
Time frame: 26 to 36 weeks
Cmax defined as the maximum observed plasma concentration.
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by t1/2
Time frame: 26 to 36 weeks
t1/2 = Elimination half-life
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Tmax
Time frame: 26 to 36 weeks
Tmax = time point at Cmax
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by total drug exposure
Time frame: 26 to 36 weeks
Total drug exposure is expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h)
4 secondary outcomes
assess the safety and tolerability of the studied drug when co-administered to HIV negative female healthy volunteers, assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
Time frame: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by Peak plasma concentration (Cmax)
Time frame: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by trough concentration (Ctrough)
Time frame: 26 to 36 weeks
investigate the association between genetic polymorphisms in drug disposition genes and drug exposure as measured by Area under the plasma concentration versus time curve (AUC)
Time frame: 26 to 36 weeks
Results and safety
The study was stopped early (reason given: Insufficient enrolment and "business reasons"). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Marta Boffito principal investigator
St Stephen's AIDS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microgynon 30® and Evotaz® in people with HIV, run by St Stephens Aids Trust at 1 site in United Kingdom.
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 15 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: stopped early, as of the sponsor's last update on 2 Jan 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 Kingdom. 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 was stopped early (reason given: Insufficient enrolment and "business reasons"). Results are not available in the source record.
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?
assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers, as measured by Cthrough (time frame: 26 to 36 weeks). The study lists 5 primary outcomes in all. 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 2 Jan 2018.