Clinical trial: Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects (NCT02256774)

Eligibility criteria:
Inclusion Criteria:

          1. Males or females who meet the inclusion/exclusion criteria, females are not pregnant
             or nursing, and agree to use a double-barrier method of birth control (condoms or
             diaphragm plus spermicide) throughout the trial (alone or in addition to other methods
             of birth control such as oral contraceptives)

          2. Age ≥18 and <60 years

          3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2

          4. Ability to give signed and dated written informed consent prior to admission to the
             study in accordance with Good Clinical Practice and the local regulations

        Exclusion Criteria:

          1. Current (symptomatic within the last 30 days) and medically relevant gastrointestinal,
             hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal
             disorders

          2. Surgery of gastrointestinal tract (except appendectomy)

          3. Currently active (symptomatic within the last 30 days) diseases of the central nervous
             system (such as epilepsy) or psychiatric disorders or neurological disorders

          4. History of relevant orthostatic hypotension, fainting spells or blackouts

          5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant
             to the trial as judged by the investigator

          6. Intake of drugs with a long half-life (>24 hours) within one month prior to
             administration of study drug or during the trial (review with clinical monitor if
             questionable)

          7. Use of drugs within 10 days prior to administration or during the trial, which might
             reasonably influence the results of the trial based on the knowledge at the time of
             protocol preparation (review with clinical monitor if questionable)

          8. Participation in another trial with an investigational drug within one month prior to
             administration or during the trial

          9. Current smoker

         10. Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit
             prescription or non-prescription drugs or drugs of abuse).

         11. Recent blood donation (more than 100 mL within 4 weeks prior to administration or
             during the trial)

         12. Excessive physical activities (within 1 week prior to study drug administration or
             during the trial)

         13. Any laboratory value outside the normal reference range that is of clinical relevance
             at screening, according to the judgment of the investigator

         14. Inability to comply with dietary regimen required by the protocol

         15. Chronic or relevant acute infections

         16. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B
             surface antigen, or hepatitis C antibody positive)

         17. HIV-1 infected as defined by a positive HIV ELISA test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 59 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment