Trial Outcomes & Findings for Post-Exposure Prophylaxis in Health Care Workers (NCT NCT01234116)

NCT ID: NCT01234116

Last Updated: 2025-08-15

Results Overview

Descriptive study describing toxicity between the 2 groups

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Variables to be measured within 4 weeks between groups.
• Results posted on: 2025-08-15

Participant Flow

Participant milestones

Measure	Kaletra Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Raltegravir Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.
Overall Study STARTED	8	8
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Exposure Prophylaxis in Health Care Workers

Baseline characteristics by cohort

Measure	Kaletra n=8 Participants Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Raltegravir n=8 Participants Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Variables to be measured within 4 weeks between groups.

Descriptive study describing toxicity between the 2 groups

Outcome measures

Measure	Kaletra n=4 Participants Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Raltegravir n=7 Participants Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.
Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests.	4 adverse events	4 adverse events

SECONDARY outcome

Timeframe: HIV ELISA measured within 24 weeks between groups

Any patient that gets HIV infected inspite of receiving PEP will be described

Outcome measures

Measure	Kaletra n=4 Participants Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Raltegravir n=7 Participants Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.
Number of Participants That Were HIV Infected	0 participants	0 participants

Adverse Events

Kaletra

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Raltegravir

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Kaletra n=4 participants at risk Arm 1: Kaletra two tabs twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.	Raltegravir n=7 participants at risk Arm 2: Raltegravir 400 mg, one pill twice a day + Truvada one pill once a day. emtricitabine/tenofovir disoproxil fumarate: Each health care worker will receive one of the Treatment Arms for 28 days.
Gastrointestinal disorders other	100.0% 4/4 • Number of events 17 • Adverse event data were collected for 4 weeks from commencement of PEP regimen	57.1% 4/7 • Number of events 5 • Adverse event data were collected for 4 weeks from commencement of PEP regimen

Additional Information

Indira Brar, MD

Henry Ford Health Sytem

Phone: 313-916-2565

Email: ibrar1@hfhs.org

Results disclosure agreements

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