Trial Outcomes & Findings for Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women (NCT NCT04900974)
NCT ID: NCT04900974
Last Updated: 2026-04-16
Results Overview
To describe single-dose total and protein-unbound Cmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Doravirine
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Doravirine
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
Baseline characteristics by cohort
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=193 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
|
Age, Continuous
|
28 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=193 Participants
|
|
Body Mass Index (BMI)
|
36.72 kg/m^2
n=193 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.To describe single-dose total and protein-unbound Cmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
2nd Trimester (20-26wks), Total
|
1340 ng/mL
Interval 884.0 to 1420.0
|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
3rd Trimester (30-34wks), Total
|
928 ng/mL
Interval 717.0 to 1500.0
|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
Post Partum (4-8wks), Total
|
1060 ng/mL
Interval 521.0 to 1720.0
|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
2nd Trimester (20-26wks), Unbound
|
252 ng/mL
Interval 194.0 to 299.0
|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
3rd Trimester (30-34wks), Unbound
|
192 ng/mL
Interval 137.0 to 303.0
|
|
Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
Post Partum (4-8wks), Unbound
|
210 ng/mL
Interval 103.0 to 350.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.To describe single-dose total and protein-unbound Tmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
2nd Trimester (20-26wks), Total
|
1 Hours
Interval 1.0 to 2.0
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
3rd Trimester (30-34wks), Total
|
1 Hours
Interval 1.0 to 4.13
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
Post Partum (4-8wks), Total
|
1.98 Hours
Interval 0.5 to 6.0
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
2nd Trimester (20-26wks), Unbound
|
1 Hours
Interval 1.0 to 2.0
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
3rd Trimester (30-34wks), Unbound
|
1 Hours
Interval 0.5 to 4.13
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
Post Partum (4-8wks), Unbound
|
1.98 Hours
Interval 0.5 to 6.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.To describe single-dose total and protein-unbound C12h of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
Post Partum (4-8wks), Unbound
|
129.798 ng/mL
Interval 58.264 to 152.312
|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
3rd Trimester (30-34wks), Unbound
|
65.124 ng/mL
Interval 51.399 to 141.189
|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
Post Partum (4-8wks), Total
|
689.500 ng/mL
Interval 281.0 to 876.0
|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
2nd Trimester (20-26wks), Unbound
|
81.620 ng/mL
Interval 53.914 to 94.074
|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
2nd Trimester (20-26wks), Total
|
431 ng/mL
Interval 260.0 to 465.0
|
|
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
3rd Trimester (30-34wks), Total
|
333 ng/mL
Interval 261.0 to 547.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.To describe single-dose total and protein-unbound C24 of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
3rd Trimester (30-34wks), Total
|
172 ng/mL
Interval 82.0 to 330.0
|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
Post Partum (4-8wks), Total
|
425 ng/mL
Interval 174.0 to 475.0
|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
2nd Trimester (20-26wks), Unbound
|
38 ng/mL
Interval 18.0 to 65.0
|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
3rd Trimester (30-34wks), Unbound
|
32 ng/mL
Interval 16.0 to 65.0
|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
Post Partum (4-8wks), Unbound
|
78 ng/mL
Interval 35.0 to 97.0
|
|
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
2nd Trimester (20-26wks), Total
|
210 ng/mL
Interval 86.0 to 292.0
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.To describe single-dose total and protein-unbound AUC of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
2nd Trimester (20-26wks), Total
|
12,219 ng*hr/mL
|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
3rd Trimester (30-34wks), Total
|
9,117 ng*hr/mL
|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
Post Partum (4-8wks), Total
|
15,880 ng*hr/mL
|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
2nd Trimester (20-26wks), Unbound
|
2,402 ng*hr/mL
|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
3rd Trimester (30-34wks), Unbound
|
1,701 ng*hr/mL
|
|
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
Post Partum (4-8wks), Unbound
|
3,156 ng*hr/mL
|
SECONDARY outcome
Timeframe: From enrollment visit to follow-up visit, an average of 10 monthsTo evaluate the number of Adverse Events reported after single doses of doravirine in pregnant participants living with HIV
Outcome measures
| Measure |
Doravirine
n=5 Participants
100mg doravirine given by mouth once at each sampling visit.
Doravirine: 100mg
|
|---|---|
|
Number of Adverse Events Reported After Single Doses of Doravirine in Pregnant Participants
|
0 adverse events
|
Adverse Events
Doravirine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amanda Poliseno
University of North Carolina at Chapel Hill
Phone: 919-962-5344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place