Clinical trial NCT02697851 (phase 1, status: terminated)
Conditions: hiv
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: microgynon 30®, evotaz®
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3, COC(=O)N[C@H](C(=O)N[C@@H](CC1=CC=CC=C1)[C@@H](O)CN(CC1=CC=C(C=C1)C1=CC=CC=N1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C
Reason stopped: 
    insufficient enrolment and "business reasons"
  
Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet all of the following inclusion criteria within 28 days prior to
             the baseline visit:

               1. 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

               2. Non-pregnant, non-lactating females.

               3. Between 18 to 35 years, inclusive

               4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive

               5. 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.

               6. 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:

                    1. is of non-child-bearing potential defined as physically incapable of
                       becoming pregnant with documented tubal ligation, hysterectomy or bilateral
                       oophorectomy or,

                    2. 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.

               7. Willing to consent to their personal details being entered onto the TOPS database

               8. Willing to provide proof of identity by photographic ID at screen and any
                  subsequent visit

               9. Registered with a GP in the UK

        Exclusion Criteria:

          -  Participants who meet any of the following exclusion criteria are not to be enrolled
             in this study.

               1. Any clinically significant acute or chronic medical illness

               2. Evidence of organ dysfunction or any clinically significant deviation from normal
                  in physical examination, vital signs, ECG or clinical laboratory determinations

               3. Positive blood screen for hepatitis B surface antigen or C antibody

               4. Positive blood screen for HIV-1 or 2 by antibody/antigen assay

               5. Current or chronic history of liver disease, or known hepatic or biliary
                  abnormalities (with the exception of Gilbert's syndrome or asymptomatic
                  gallstones)

               6. Any medical contra-indication to the use of combined oral contraceptives.

               7. 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)

               8. Current or recent (within three months) gastrointestinal disease

               9. Known intolerance of lactose monohydrate, sunset yellow aluminium lake (E110),
                  and patients with galactose intolerance, the Lapp lactase deficiency, or
                  glucose-galactose malabsorption

              10. 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

              11. 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

              12. Use of any medical products containing estrogens and/or progesteron, including
                  IUS, implants etc. for 4 weeks before screening

              13. 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

              14. 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