Trial Outcomes & Findings for Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers (NCT NCT05648201)
NCT ID: NCT05648201
Last Updated: 2026-04-16
Results Overview
Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
24hours after ingestion of study drug
Results posted on
2026-04-16
Participant Flow
Participant milestones
| Measure |
Doravirine
1 single dose of 100mg doravirine taken orally
Doravirine 100Mg Tab: 1 single dose of 100mg taken orally
|
Biktarvy
1 single dose of 25/200/50mg taken orally
Biktarvy 50/200/25 Tab: 1 single dose of 50/200/25 taken orally
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
COMPLETED
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
Baseline characteristics by cohort
| Measure |
Doravirine
n=8 Participants
1 single dose of 100mg doravirine taken orally
Doravirine 100Mg Tab: 1 single dose of 100mg taken orally
|
Biktarvy
n=12 Participants
1 single dose of 25/200/50mg taken orally
Biktarvy 50/200/25 Tab: 1 single dose of 50/200/25 taken orally
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
8 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Continuous
|
32 years
n=193 Participants
|
33 years
n=193 Participants
|
33 years
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
20 Participants
n=386 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=193 Participants
|
12 participants
n=193 Participants
|
20 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: 24hours after ingestion of study drugArea under the plasma and milk concentration curve are used to calculate milk to plasma ratio
Outcome measures
| Measure |
Doravirine
n=8 Participants
1 single dose of 100mg doravirine taken orally
Doravirine 100Mg Tab: 1 single dose of 100mg taken orally
|
Biktarvy
n=12 Participants
1 single dose of 25/200/50mg taken orally
Biktarvy 50/200/25 Tab: 1 single dose of 50/200/25 taken orally
|
|---|---|---|
|
M:P Ratio
|
0.26 ratio
Geometric Coefficient of Variation 21
|
0.0085 ratio
Geometric Coefficient of Variation 19.4
|
SECONDARY outcome
Timeframe: 24hours after ingestion of study drugAUC over dosing interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 24 hours after ingestion of study drugPeak plasma concentration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24hours after ingestion of study drugConcentration at the end of dosing interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24hours after ingestion of study drugClearance of the study drugs
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24hours after ingestion of study drugApparent volume of distribution of study drug
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24hours after ingestion of study drugHalf life of study drug
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24hours after ingestion of study drugConcentrations in breastmilk will be extrapolated to infant dosages
Outcome measures
Outcome data not reported
Adverse Events
Doravirine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Biktarvy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doravirine
n=8 participants at risk
1 single dose of 100mg doravirine taken orally
Doravirine 100Mg Tab: 1 single dose of 100mg taken orally
|
Biktarvy
n=12 participants at risk
1 single dose of 25/200/50mg taken orally
Biktarvy 50/200/25 Tab: 1 single dose of 50/200/25 taken orally
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • One week after study drug intake
|
0.00%
0/12 • One week after study drug intake
|
|
Nervous system disorders
Dizzyness
|
12.5%
1/8 • Number of events 1 • One week after study drug intake
|
8.3%
1/12 • Number of events 1 • One week after study drug intake
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • One week after study drug intake
|
25.0%
3/12 • Number of events 3 • One week after study drug intake
|
|
Infections and infestations
Flu-like symptoms
|
25.0%
2/8 • Number of events 2 • One week after study drug intake
|
16.7%
2/12 • Number of events 2 • One week after study drug intake
|
|
Metabolism and nutrition disorders
Elevated bilirubin
|
12.5%
1/8 • Number of events 1 • One week after study drug intake
|
8.3%
1/12 • Number of events 1 • One week after study drug intake
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place