Phase 2
Completed N=13
Efavirenz and Ritonavir on Human Brain P-Glycoprotein
Drug Effects
Source: ClinicalTrials.gov NCT01668147 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Cerebral [11C]dLop Distribution Volume
Summary
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral [11C]dLop Distribution Volume |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female, 18-40 yr old
- Good general health with no remarkable medical conditions
- BMI 110 mg/dl
- Family history of type 2 diabetes
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
- Females who are pregnant or nursing
- Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
- Contraindications to MRI
- Contraindications to PET scanning
Data sourced from ClinicalTrials.gov (NCT01668147). 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.