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Emtricitabine/Tenofovir Alafenamide as Salvage ART

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: NCT02556333
Recruitment Status : Terminated
First Posted : September 22, 2015
Results First Posted : October 17, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Intervention Drug: FTC/TAF
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAF Treatment
Hide Arm/Group Description Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title TAF Treatment
Hide Arm/Group Description Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title HIV RNA Change From Baseline to Day 10
Hide Description An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
One patient with multiple drug resistant HIV infection enrolled into this study.
Arm/Group Title TAF Treatment
Hide Arm/Group Description:
Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: log HIV RNA copies/mL
0.01
Time Frame 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAF Treatment
Hide Arm/Group Description Each subject receives tenofovir alafenamide (TAF) with emtricitabine to be added to a failing antiretroviral regimen for 10 days, if there is a HIV RNA response of >= 0.5 log decline, subjects will continue of TAF with emtricitabine with a new optimized background regimen. If <0.5 log decline, TAF with emtricitabine will be discontinued and study enrollment for the subject will be terminated.
All-Cause Mortality
TAF Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TAF Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAF Treatment
Affected / at Risk (%)
Total   0/1 (0.00%) 
The study was approved in late 2015, with the first and only patient enrolled in Jan 2016. The drug was approved in April 2016, which resulted in termination of the protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Alice Pau, Pharm.D., Staff Scientist (Clinical)
Organization: National Institutes of Health, National Institute of Allergy and Infectious Diseases
Phone: 301-451-3740
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02556333     History of Changes
Other Study ID Numbers: 150201
15-I-0201 ( Other Identifier: NIH )
First Submitted: September 18, 2015
First Posted: September 22, 2015
Results First Submitted: August 15, 2017
Results First Posted: October 17, 2017
Last Update Posted: November 14, 2017