Trial Outcomes & Findings for HIV Non Occupational Post-Exposure Prophylaxis (PEP) (NCT NCT00594646)

NCT ID: NCT00594646

Last Updated: 2022-10-25

Results Overview

Pill counts performed at 14 and 28 days

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2022-10-25

Participant Flow

Participants were recruited from Fenway Health. Patients at least 18 years of age, who contacted Fenway Health and presented within 72 hours after a potential sexual exposure to HIV-1 were asked to participate in this study.

If study coordinator is notified more than 72 hours after exposure occurred, person will not be eligible for study participation; however they will be referred to an on call medical provider for Non Occupational Post-Exposure Prophylaxis evaluation.

Participant milestones

Measure	TRUVADA + Raltegravir Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
Overall Study STARTED	100
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	TRUVADA + Raltegravir Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	15

Baseline Characteristics

HIV Non Occupational Post-Exposure Prophylaxis (PEP)

Baseline characteristics by cohort

Measure	Group 1 n=100 Participants TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
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	33.3 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 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: 28 days

Pill counts performed at 14 and 28 days

Outcome measures

Measure	Group 1 n=100 Participants TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
Medication Regimen Completion Rates Completed as prescribed	57 participants
Medication Regimen Completion Rates Stopped or Modified regimen	28 participants
Medication Regimen Completion Rates Lost to follow-up	15 participants

PRIMARY outcome

Timeframe: 90 days

Population: Participants evaluable at 3 months (90 days) after treatment initiation

Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected

Outcome measures

Measure	Group 1 n=85 Participants TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
Number of HIV-1 Infected Participants	0 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=100 participants at risk TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
Gastrointestinal disorders Diarrhea / Loose Stool / Soft Stool	21.0% 21/100 • 28 days
General disorders Fatigue	14.0% 14/100 • 28 days
Gastrointestinal disorders Abdominal discomfort, pain, gas, or bloating	16.0% 16/100 • 28 days
Gastrointestinal disorders Nausea/vomiting	27.0% 27/100 • 28 days
Nervous system disorders Headache	15.0% 15/100 • 28 days

Additional Information

Dr. Kenneth Mayer

Fenway Health

Phone: 617-927-6400

Email: kmayer@fenwayhealth.org

Results disclosure agreements

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