Trial Outcomes & Findings for Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP) (NCT NCT01214759)

NCT ID: NCT01214759

Last Updated: 2016-02-08

Results Overview

This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-02-08

Participant Flow

Participant milestones

Measure	Truvada and Raltegravir Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day
Overall Study STARTED	103
Overall Study 28 Days nPEP Completion	85
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

Baseline characteristics by cohort

Measure	Truvada and Raltegravir n=103 Participants Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day
Age, Continuous	32 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All who completed all study visits

This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.

Outcome measures

Measure	Truvada and Raltegravir n=55 Participants Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day
Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months	0 participants

SECONDARY outcome

Timeframe: 28 days

Population: Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.

Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

Population: All who were enrolled

Outcome measures

Measure	Truvada and Raltegravir n=103 Participants Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day
Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study	85 participants

Adverse Events

Truvada and Raltegravir

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Truvada and Raltegravir n=85 participants at risk Single arm Truvada: Tenofovir 200mg/emtricitabine 300mg once a day Raltegravir: Raltegravir 400mg twice a day
General disorders Headache	7.1% 6/85 • Number of events 6 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Fatigue	5.9% 5/85 • Number of events 5 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Gastrointestinal disorders Nausea	4.7% 4/85 • Number of events 4 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Dizziness	2.4% 2/85 • Number of events 2 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Gastrointestinal disorders Constipation	2.4% 2/85 • Number of events 2 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Gastrointestinal disorders Bloating	2.4% 2/85 • Number of events 2 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Flushing	2.4% 2/85 • Number of events 2 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Gastrointestinal disorders Loose stools	2.4% 2/85 • Number of events 2 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Reproductive system and breast disorders Delayed menstruation	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Decreased appetite	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Nightmares	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Insomnia	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
Gastrointestinal disorders Abdominal pain	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.
General disorders Face pain	1.2% 1/85 • Number of events 1 • Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months. All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.

Additional Information

Dr. Karen Vigil

The University of Texas Health Science Center at Houston

Phone: (713) 500-6703

Email: Karen.J.Vigil@uth.tmc.edu

Results disclosure agreements

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