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

NCT01896622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ritonavir

Impact on dabigatran PK/PD

DRUG

Cobicistat

Impact on dabigatran PK/PD

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Colleen M Hadigan, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-18
Primary Completion
2017-01-17
Completion
2017-01-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896622 on ClinicalTrials.gov