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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01214759
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Gilead Sciences
Information provided by (Responsible Party):
Karen Vigil, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV
Interventions Drug: Truvada
Drug: Raltegravir
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

Period Title: Overall Study
Started 103
28 Days nPEP Completion 85
Completed 55
Not Completed 48
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
All who were enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
32  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
11
  10.7%
Male
92
  89.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 103 participants
103
1.Primary Outcome
Title Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All who completed all study visits
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description:

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description:

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All who were enrolled
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description:

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
85
Time Frame Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months.
Adverse Event Reporting Description 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.
 
Arm/Group Title Truvada and Raltegravir
Hide Arm/Group Description

Single arm

Truvada: Tenofovir 200mg/emtricitabine 300mg once a day

Raltegravir: Raltegravir 400mg twice a day

All-Cause Mortality
Truvada and Raltegravir
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Truvada and Raltegravir
Affected / at Risk (%) # Events
Total   0/85 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Truvada and Raltegravir
Affected / at Risk (%) # Events
Total   8/85 (9.41%)    
Gastrointestinal disorders   
Nausea   4/85 (4.71%)  4
Constipation   2/85 (2.35%)  2
Bloating   2/85 (2.35%)  2
Loose stools   2/85 (2.35%)  2
Abdominal pain   1/85 (1.18%)  1
General disorders   
Headache   6/85 (7.06%)  6
Fatigue   5/85 (5.88%)  5
Dizziness   2/85 (2.35%)  2
Flushing   2/85 (2.35%)  2
Decreased appetite   1/85 (1.18%)  1
Nightmares   1/85 (1.18%)  1
Insomnia   1/85 (1.18%)  1
Face pain   1/85 (1.18%)  1
Reproductive system and breast disorders   
Delayed menstruation   1/85 (1.18%)  1
Indicates events were collected by systematic assessment
This is a pilot study with a small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Karen Vigil
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-6703
EMail: Karen.J.Vigil@uth.tmc.edu
Layout table for additonal information
Responsible Party: Karen Vigil, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01214759    
Other Study ID Numbers: UT-NPEP
First Submitted: September 30, 2010
First Posted: October 5, 2010
Results First Submitted: January 7, 2016
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016