Trial Outcomes & Findings for Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men (NCT NCT03980223)
NCT ID: NCT03980223
Last Updated: 2024-07-12
Results Overview
Number of quarterly visits with an STI event detected.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
641 participants
Primary outcome timeframe
1 year
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
PrEP Cohort: Doxy PEP
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PrEP Cohort: Control
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
PLWH Cohort: Doxy PEP
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PLWH: Control
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
292
|
140
|
141
|
68
|
|
Overall Study
COMPLETED
|
217
|
100
|
109
|
47
|
|
Overall Study
NOT COMPLETED
|
75
|
40
|
32
|
21
|
Reasons for withdrawal
| Measure |
PrEP Cohort: Doxy PEP
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PrEP Cohort: Control
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
PLWH Cohort: Doxy PEP
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PLWH: Control
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
10
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Not included because they had not yet reached month 3 visit at time of analysis
|
72
|
33
|
20
|
11
|
Baseline Characteristics
Data not available for 19 participants.
Baseline characteristics by cohort
| Measure |
PrEP Cohort: Doxy PEP
n=220 Participants
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PrEP Cohort: Control
n=107 Participants
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
PLWH Cohort: Doxy PEP
n=119 Participants
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP).
|
PLWH Cohort: Control
n=55 Participants
The control arm will consist of standard of care STI testing and treatment - People living with HIV
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Median age
|
36 Years
n=220 Participants
|
36 Years
n=107 Participants
|
43 Years
n=119 Participants
|
42 Years
n=55 Participants
|
38 Years
n=501 Participants
|
|
Sex/Gender, Customized
Gender identity · Man
|
212 Participants
n=220 Participants
|
107 Participants
n=107 Participants
|
109 Participants
n=119 Participants
|
54 Participants
n=55 Participants
|
482 Participants
n=501 Participants
|
|
Sex/Gender, Customized
Gender identity · Transgender woman or gender-diverse
|
8 Participants
n=220 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=119 Participants
|
1 Participants
n=55 Participants
|
19 Participants
n=501 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=220 Participants
|
41 Participants
n=107 Participants
|
41 Participants
n=119 Participants
|
14 Participants
n=55 Participants
|
151 Participants
n=501 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
165 Participants
n=220 Participants
|
66 Participants
n=107 Participants
|
78 Participants
n=119 Participants
|
41 Participants
n=55 Participants
|
350 Participants
n=501 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=220 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=501 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
144 Participants
n=209 Participants • Data not available for 19 participants.
|
66 Participants
n=104 Participants • Data not available for 19 participants.
|
74 Participants
n=116 Participants • Data not available for 19 participants.
|
37 Participants
n=53 Participants • Data not available for 19 participants.
|
321 Participants
n=482 Participants • Data not available for 19 participants.
|
|
Race/Ethnicity, Customized
Race · Black
|
9 Participants
n=209 Participants • Data not available for 19 participants.
|
5 Participants
n=104 Participants • Data not available for 19 participants.
|
15 Participants
n=116 Participants • Data not available for 19 participants.
|
7 Participants
n=53 Participants • Data not available for 19 participants.
|
36 Participants
n=482 Participants • Data not available for 19 participants.
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
33 Participants
n=209 Participants • Data not available for 19 participants.
|
12 Participants
n=104 Participants • Data not available for 19 participants.
|
7 Participants
n=116 Participants • Data not available for 19 participants.
|
1 Participants
n=53 Participants • Data not available for 19 participants.
|
53 Participants
n=482 Participants • Data not available for 19 participants.
|
|
Race/Ethnicity, Customized
Race · Multiple races or other
|
23 Participants
n=209 Participants • Data not available for 19 participants.
|
21 Participants
n=104 Participants • Data not available for 19 participants.
|
20 Participants
n=116 Participants • Data not available for 19 participants.
|
8 Participants
n=53 Participants • Data not available for 19 participants.
|
72 Participants
n=482 Participants • Data not available for 19 participants.
|
|
Region of Enrollment
United States
|
220 participants
n=220 Participants
|
107 participants
n=107 Participants
|
119 participants
n=119 Participants
|
55 participants
n=55 Participants
|
501 participants
n=501 Participants
|
|
Gender of sexual partners
Men only
|
191 Participants
n=220 Participants • Data not available for 1 participant.
|
90 Participants
n=107 Participants • Data not available for 1 participant.
|
105 Participants
n=118 Participants • Data not available for 1 participant.
|
48 Participants
n=55 Participants • Data not available for 1 participant.
|
434 Participants
n=500 Participants • Data not available for 1 participant.
|
|
Gender of sexual partners
Multiple genders
|
29 Participants
n=220 Participants • Data not available for 1 participant.
|
17 Participants
n=107 Participants • Data not available for 1 participant.
|
13 Participants
n=118 Participants • Data not available for 1 participant.
|
7 Participants
n=55 Participants • Data not available for 1 participant.
|
66 Participants
n=500 Participants • Data not available for 1 participant.
|
|
Annual income
<$20,000
|
31 Participants
n=219 Participants • Data not available for 2 participants.
|
13 Participants
n=106 Participants • Data not available for 2 participants.
|
42 Participants
n=119 Participants • Data not available for 2 participants.
|
17 Participants
n=55 Participants • Data not available for 2 participants.
|
103 Participants
n=499 Participants • Data not available for 2 participants.
|
|
Annual income
$20,001-$50,000
|
64 Participants
n=219 Participants • Data not available for 2 participants.
|
39 Participants
n=106 Participants • Data not available for 2 participants.
|
40 Participants
n=119 Participants • Data not available for 2 participants.
|
22 Participants
n=55 Participants • Data not available for 2 participants.
|
165 Participants
n=499 Participants • Data not available for 2 participants.
|
|
Annual income
$50,001-$75,000
|
45 Participants
n=219 Participants • Data not available for 2 participants.
|
14 Participants
n=106 Participants • Data not available for 2 participants.
|
22 Participants
n=119 Participants • Data not available for 2 participants.
|
5 Participants
n=55 Participants • Data not available for 2 participants.
|
86 Participants
n=499 Participants • Data not available for 2 participants.
|
|
Annual income
>$75,000
|
79 Participants
n=219 Participants • Data not available for 2 participants.
|
40 Participants
n=106 Participants • Data not available for 2 participants.
|
15 Participants
n=119 Participants • Data not available for 2 participants.
|
11 Participants
n=55 Participants • Data not available for 2 participants.
|
145 Participants
n=499 Participants • Data not available for 2 participants.
|
|
STI in the past 12 months
Gonorrhea
|
155 Participants
n=220 Participants
|
78 Participants
n=107 Participants
|
71 Participants
n=119 Participants
|
39 Participants
n=55 Participants
|
343 Participants
n=501 Participants
|
|
STI in the past 12 months
Chlamydia
|
144 Participants
n=220 Participants
|
63 Participants
n=107 Participants
|
58 Participants
n=119 Participants
|
27 Participants
n=55 Participants
|
292 Participants
n=501 Participants
|
|
STI in the past 12 months
Syphillis
|
32 Participants
n=220 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=119 Participants
|
17 Participants
n=55 Participants
|
100 Participants
n=501 Participants
|
|
Two or more STIs in the past 12 months
|
106 Participants
n=220 Participants
|
44 Participants
n=107 Participants
|
39 Participants
n=119 Participants
|
26 Participants
n=55 Participants
|
215 Participants
n=501 Participants
|
|
STI at baseline
Gonorrhea
|
40 Participants
n=218 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
20 Participants
n=107 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
25 Participants
n=117 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
14 Participants
n=54 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
99 Participants
n=496 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
|
STI at baseline
Chlamydia
|
31 Participants
n=219 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
11 Participants
n=107 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
11 Participants
n=117 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
8 Participants
n=54 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
61 Participants
n=497 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
|
STI at baseline
Syphilis
|
5 Participants
n=219 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
1 Participants
n=107 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
11 Participants
n=117 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
4 Participants
n=55 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
21 Participants
n=498 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
|
STI at baseline
Any STI at baseline
|
65 Participants
n=219 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
27 Participants
n=106 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
34 Participants
n=114 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
20 Participants
n=55 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
146 Participants
n=494 Participants • Data was not available for participants as follows: * Gonorrhea: 5 participants * Chlamydia: 4 participants * Syphilis: 3 participants * Any STI: 7 participants
|
|
Median number of sexual partners in past 3 months
|
8 partners
n=220 Participants
|
10 partners
n=107 Participants
|
7 partners
n=119 Participants
|
10.5 partners
n=55 Participants
|
9 partners
n=501 Participants
|
|
Transactional sex during lifetime
|
47 Participants
n=219 Participants • Data not available for 10 participants
|
28 Participants
n=107 Participants • Data not available for 10 participants
|
47 Participants
n=116 Participants • Data not available for 10 participants
|
21 Participants
n=49 Participants • Data not available for 10 participants
|
143 Participants
n=491 Participants • Data not available for 10 participants
|
|
Substance use in the past 3 months
Stimulants: methamphetamine, cocaine, or crack
|
51 Participants
n=216 Participants • Data not available for 8 participants.
|
22 Participants
n=107 Participants • Data not available for 8 participants.
|
50 Participants
n=117 Participants • Data not available for 8 participants.
|
23 Participants
n=53 Participants • Data not available for 8 participants.
|
146 Participants
n=493 Participants • Data not available for 8 participants.
|
|
Substance use in the past 3 months
Heroin or other opioids
|
2 Participants
n=216 Participants • Data not available for 8 participants.
|
1 Participants
n=107 Participants • Data not available for 8 participants.
|
9 Participants
n=117 Participants • Data not available for 8 participants.
|
2 Participants
n=53 Participants • Data not available for 8 participants.
|
14 Participants
n=493 Participants • Data not available for 8 participants.
|
|
Substance use in the past 3 months
Ecstasy, GHB, or ketamine
|
63 Participants
n=216 Participants • Data not available for 8 participants.
|
34 Participants
n=107 Participants • Data not available for 8 participants.
|
39 Participants
n=117 Participants • Data not available for 8 participants.
|
21 Participants
n=53 Participants • Data not available for 8 participants.
|
157 Participants
n=493 Participants • Data not available for 8 participants.
|
|
Substance use in the past 3 months
Amyl nitrates, also known as poppers
|
93 Participants
n=216 Participants • Data not available for 8 participants.
|
47 Participants
n=107 Participants • Data not available for 8 participants.
|
56 Participants
n=117 Participants • Data not available for 8 participants.
|
28 Participants
n=53 Participants • Data not available for 8 participants.
|
224 Participants
n=493 Participants • Data not available for 8 participants.
|
|
Substance use in the past 3 months
Marijuana
|
96 Participants
n=216 Participants • Data not available for 8 participants.
|
56 Participants
n=107 Participants • Data not available for 8 participants.
|
60 Participants
n=117 Participants • Data not available for 8 participants.
|
27 Participants
n=53 Participants • Data not available for 8 participants.
|
239 Participants
n=493 Participants • Data not available for 8 participants.
|
|
Substance use in the past 3 months
Total with any substance use in past 3 months
|
112 Participants
n=216 Participants • Data not available for 8 participants.
|
66 Participants
n=107 Participants • Data not available for 8 participants.
|
77 Participants
n=117 Participants • Data not available for 8 participants.
|
38 Participants
n=53 Participants • Data not available for 8 participants.
|
293 Participants
n=493 Participants • Data not available for 8 participants.
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Primary efficacy analysis population excludes participants who did not attend any follow-up visits after baseline.
Number of quarterly visits with an STI event detected.
Outcome measures
| Measure |
PrEP Cohort: Doxy PEP
n=570 Total number of quarterly visits
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PrEP Cohort: Control
n=257 Total number of quarterly visits
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
PLWH Cohort: Doxy PEP
n=305 Total number of quarterly visits
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
|
PLWH: Control
n=128 Total number of quarterly visits
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
|
|---|---|---|---|---|
|
Number of Quarterly Visits In Which an STI Was Detected
|
61 No. quarterly visits with STI event
|
82 No. quarterly visits with STI event
|
36 No. quarterly visits with STI event
|
39 No. quarterly visits with STI event
|
Adverse Events
PrEP Cohort: Doxy PEP
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PrEP Cohort: Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PLWH Cohort: Doxy PEP
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
PLWH: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PrEP Cohort: Doxy PEP
n=217 participants at risk
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP).
The number of participants assessed for serious and non-serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PrEP Cohort: Control
n=100 participants at risk
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
The number of participants assessed for serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PLWH Cohort: Doxy PEP
n=109 participants at risk
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP).
The number of participants assessed for serious and non-serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PLWH: Control
n=47 participants at risk
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
The number of participants assessed for serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Cat bite
|
0.00%
0/217 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/100 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.92%
1/109 • Number of events 1 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/47 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.46%
1/217 • Number of events 1 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/100 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/109 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/47 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/217 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/100 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.92%
1/109 • Number of events 1 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/47 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/217 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
1.0%
1/100 • Number of events 1 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/109 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/47 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
Other adverse events
| Measure |
PrEP Cohort: Doxy PEP
n=217 participants at risk
Doxycycline 200mg in addition to standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP).
The number of participants assessed for serious and non-serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PrEP Cohort: Control
n=100 participants at risk
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
The number of participants assessed for serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PLWH Cohort: Doxy PEP
n=109 participants at risk
Doxycycline 200mg in addition to standard of care STI testing and treatment - People living with HIV Doxycycline Hyclate Delayed-Release 200 mg: 200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP).
The number of participants assessed for serious and non-serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
PLWH: Control
n=47 participants at risk
The control arm will consist of standard of care STI testing and treatment - HIV-negative participants on PrEP at time of enrollment or starting PrEP within 30 days of enrollment.
The number of participants assessed for serious adverse events excludes those who did not attend any follow-up visits after baseline.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
3/217 • Number of events 3 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/109 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
|
Hepatobiliary disorders
Elevated ALT
|
0.46%
1/217 • Number of events 1 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/109 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
|
Nervous system disorders
Headache/migraine
|
0.92%
2/217 • Number of events 2 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
0.00%
0/109 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
—
0/0 • Duration of participants participation, up to 1 year.
The following AEs were recorded at each study visit: * All grade 2 and higher hematologic and hepatic laboratory abnormalities that are attributed to doxycycline in the opinion of the site investigator * All AEs meeting SAE definition * All grade 3 and 4 adverse events judged to be associated with doxycycline (possibly, probably, or definitely related) * NOTE: Non-serious adverse events were not collected or reported in participants assigned to a control arm, per protocol.
|
Additional Information
Anne Luetkemeyer
University of California, San Francisco
Phone: 415-502-5753
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place