Sustiva Levels With Use of a Gel Capsule

University of Minnesota (UMN)

Status and phase: Completed; Phase 4

Conditions: HIV; HIV Infections

Treatments: Drug: Over-encapsulated efavirenz; Drug: Efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT01087814

0910M73917

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

efavirenz

Active Comparator group

Treatment:

Drug: Efavirenz

over-encapsulated efavirenz

Experimental group

Treatment:

Drug: Over-encapsulated efavirenz