Trial Outcomes & Findings for HIV Non-Occupational Post-Exposure Prophylaxis (NCT NCT01855867)

NCT ID: NCT01855867

Last Updated: 2022-04-19

Results Overview

The number of adverse events reported

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2022-04-19

Participant Flow

Participant milestones

Measure	Stribild Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Non-Occupational Post-Exposure Prophylaxis

Baseline characteristics by cohort

Measure	Stribild n=100 Participants Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.1 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 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	8 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	9 Participants n=5 Participants
Race (NIH/OMB) White	83 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	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: 100 participants were enrolled

The number of adverse events reported

Outcome measures

Measure	Stribild n=100 Participants Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Number of Adverse Event Occurrences Diarrhea	38 events
Number of Adverse Event Occurrences Fatigue	28 events
Number of Adverse Event Occurrences Nausea/Vomiting	28 events
Number of Adverse Event Occurrences Headache	14 events
Number of Adverse Event Occurrences Dizziness/Lightheadness	6 events
Number of Adverse Event Occurrences Body Aches/Muscle and Joint Pain	2 events

SECONDARY outcome

Timeframe: Day 30

self-reported missed doses

Outcome measures

Measure	Stribild n=100 Participants Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Number of Participants With Self-Reported Missed Doses	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90

Outcome measures

Measure	Stribild n=100 Participants Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
nPEP Failure (HIV Infection During Study Participation)	0 reactive test

Adverse Events

Stribild

Serious events: 0 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Stribild n=100 participants at risk Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
Gastrointestinal disorders Diarrhea	38.0% 38/100 • Number of events 38 • 90 days
Nervous system disorders Fatigue	28.0% 28/100 • Number of events 28 • 90 days
Gastrointestinal disorders Nausea/vomiting	28.0% 28/100 • Number of events 28 • 90 days
Nervous system disorders headache	18.0% 18/100 • Number of events 18 • 90 days
Nervous system disorders dizziness/lightheadedness	6.0% 6/100 • Number of events 6 • 90 days
Musculoskeletal and connective tissue disorders body/muscle/joint aches	2.0% 2/100 • Number of events 2 • 90 days

Additional Information

Dr. Kenneth Mayer, Medical Research Director

The Fenway Institute

Phone: 6179276374

Email: kmayer@fenwayhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place