NCT01896622

The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Ritonavir in HIV in 40 participants. Completed in 17 January 2017.

Timeline

18 June 2013

Primary endpoint
17 January 2017

17 January 2017

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	18 June 2013
Primary completion	17 January 2017
Estimated completion	17 January 2017
Sites	1 location across United States

Drugs / interventions tested

• Ritonavir (ritonavir) — full drug profile →
• Cobicistat (COBICISTAT) — full drug profile →

Conditions studied

• HIV — all drugs for HIV →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 70, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People who have the human immunodeficiency virus (HIV) often take several medications to control their disease. They may also need to take medicine to prevent blood clots. Taking both kinds of medicine together can cause bleeding or other problems. But this might not happen if the medications are taken at different times. Researchers will study two particular HIV drugs (ritonavir and cobicistat) and how they interact with blood clot medications.

Objectives:

-To understand how HIV medicine and blood clot medicine interact, so doctors can choose what to prescribe for people who take both.

Eligibility:

\- Healthy adults between 18 and 70 years old who are not on any medications.

Design:

* Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant.
* Participants will visit the National Institutes of Health 7 times after the screening visit. Three visits will last about 12 hours. The other 4 will last about 1 hour.
* Participants will take a daily dose of either study medication for 22 days. They will keep a diary of medicine they take and any side effects.
* Treatment will be monitored with blood tests over about 2 months.
* When the study of one drug is completed, the next drug study will begin with a different group of participants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Differential Influence of the Antiretroviral Pharmacokinetic Enhancers Ritonavir and Cobicistat on Intestinal P-Glycoprotein Transport and the Pharmacokinetic/Pharmacodynamic Disposition of Dabigatran.
   Kumar P, Gordon LA, Brooks KM, George JM, et al · · 2017 · cited 39× · PMID 28848011 · DOI 10.1128/aac.01201-17
2. Antiretroviral Boosting Agent Cobicistat Increases the Pharmacokinetic Exposure and Anticoagulant Effect of Dabigatran in HIV-Negative Healthy Volunteers.
   Gordon LA, Kumar P, Brooks KM, Kellogg A, et al · · 2016 · cited 20× · PMID 27920076 · DOI 10.1161/circulationaha.116.025257