Trial Outcomes & Findings for Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens (NCT NCT04860505)
NCT ID: NCT04860505
Last Updated: 2023-05-23
Results Overview
Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
COMPLETED
PHASE4
20 participants
24 hours after a single dose
2023-05-23
Participant Flow
Participants were recruited from the Hope Clinic in Atlanta, Georgia, USA. Participant enrollment began May 20, 2021 and all follow-up assessments were completed by May 9, 2022.
Participant milestones
| Measure |
Doxycycline and Biktarvy
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
Doxycycline (DOX \[200 mg\]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.
Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
|
|---|---|
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Overall Study
STARTED
|
20
|
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Overall Study
Attended 24 Hours Post-dose Visit
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Doxycycline and Biktarvy
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
Doxycycline (DOX \[200 mg\]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.
Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Baseline characteristics by cohort
| Measure |
Doxycycline and Biktarvy
n=20 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after a single dosePopulation: This analysis includes participants who completed the rectal biopsy during the 24-hours post-dose visit. Ten men and 5 women provided rectal tissue samples at the 24-hours post-dose visit. One male attended the visit but was not able to tolerate the biopsy procedure and no rectal tissue was obtained.
Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
Outcome measures
| Measure |
Doxycycline and Biktarvy
n=15 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
|
|---|---|
|
Rectal Doxycycline Concentration
|
0.654 µg/g
Interval 0.305 to 1.237
|
PRIMARY outcome
Timeframe: 24 hours after a single dosePopulation: One female attended the visit 24 hours post-dose but was not able to proceed with the vaginal biopsy procedure due to menses and vaginal rugae.
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Outcome measures
| Measure |
Doxycycline and Biktarvy
n=8 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
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|---|---|
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Vaginal Doxycycline Concentration
|
0.367 µg/g
Interval 0.203 to 1.445
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PRIMARY outcome
Timeframe: 24 hours after a single doseDoxycycline concentration in plasma was measured.
Outcome measures
| Measure |
Doxycycline and Biktarvy
n=20 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
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|---|---|
|
Plasma Doxycycline Concentration
|
487 µg/mL
Interval 305.0 to 824.0
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SECONDARY outcome
Timeframe: 24 hours after a single dosePopulation: This analysis includes participants who completed the rectal biopsy during the 24-hours post-dose visit. Ten men and 5 women provided rectal tissue samples at the 24-hours post-dose visit. One male attended the visit but was not able to tolerate the biopsy procedure and no rectal tissue was obtained.
Bectegravir concentration in tissue from a rectal biopsy was measured.
Outcome measures
| Measure |
Doxycycline and Biktarvy
n=15 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
|
|---|---|
|
Rectal Bictegravir Concentration
|
0.085 µg/g
Interval to 0.391
The lowest value is below the limit of detection of 0.010.
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SECONDARY outcome
Timeframe: 24 hours after a single dosePopulation: One female attended the visit 24 hours post-dose but was not able to proceed with the vaginal biopsy procedure due to menses and vaginal rugae.
Bictegravir concentration in tissue from a vaginal biopsy was measured.
Outcome measures
| Measure |
Doxycycline and Biktarvy
n=8 Participants
Participants took both study drugs simultaneously at home and came to the clinic for a study visit the following day for samples to be obtained 24 hours after the single dose of study drugs.
|
|---|---|
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Vaginal Bictegravir Concentration
|
0.207 µg/g
Interval to 1.038
The lowest value is below the limit of detection of 0.010.
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Adverse Events
Doxycycline and Biktarvy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place