NCT02697851

The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women

Terminated Phase 1 Last updated 29 December 2017

What this trial tests

Phase 1 trial testing Microgynon 30® in HIV in 13 participants. Terminated before completion.

Timeline

1 July 2016

Primary endpoint
31 October 2017

31 October 2017

Quick facts

Lead sponsor	St Stephens Aids Trust
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	13
Start date	1 July 2016
Primary completion	31 October 2017
Estimated completion	31 October 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Microgynon 30® — full drug profile →
• Evotaz® — full drug profile →

Conditions studied

• HIV — all drugs for HIV →

Sponsor

St Stephens Aids Trust — full company profile →

Who can join

Adults 18 to 35, female only, with HIV. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.