HIV, HIV Infections
Conditions
Keywords
efavirenz, Sustiva, pharmacokinetics
Brief 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.
Interventions
DRUGEfavirenz
Subject will take efavirenz for 5 days.
DRUGOver-encapsulated efavirenz
Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Levels of Efavirenz | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Efavirenz Both arms received both versions of the drug during the course of the study. | 8 |
| Over-encapsulated Efavirenz Both arms received both versions of the drug over the course of the study. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (5 Days) | Withdrawal by Subject | 3 | 1 |
| Second Intervention (5 Days) | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Over-encapsulated Efavirenz | Efavirenz | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 25.875 years STANDARD_DEVIATION 2.53194 | 26.125 years STANDARD_DEVIATION 8.45893 | 26 years STANDARD_DEVIATION 6.03324 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Serum Levels of Efavirenz
Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.
Time frame: 5th day of taking drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Efavirenz (Tablet) | Serum Levels of Efavirenz | 5151.11 ng/mL | Standard Deviation 765.67 |
| Over-encapsulated Efavirenz | Serum Levels of Efavirenz | 4965.08 ng/mL | Standard Deviation 1285.48 |