Sustiva Levels With Use of a Gel Capsule

We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

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Key information

Conditions

HIV Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV-negative, proven by ELISA
Age: ≥ 18 years old

Exclusion criteria

Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.

Treatment and study plan

Efavirenz

Drug

Subject will take efavirenz for 5 days.

Other names: Sustiva

Over-encapsulated efavirenz

Drug

Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.

Other names: Over-encapsulated Sustiva

Primary outcomes

Serum Levels of Efavirenz

Time frame: 5th day of taking drug

Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Effect of Encapsulation Upon Efavirenz Pharmacokinetics

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Mar 16, 2010
Registry last updated: Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed