Phase 4
Completed N=15
Sustiva Levels With Use of a Gel Capsule
Source: ClinicalTrials.gov NCT01087814 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Serum Levels of Efavirenz — 5151.11; 4965.08 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Levels of Efavirenz |
5151.11; 4965.08 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01087814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.