Trial Outcomes & Findings for Emtricitabine/Tenofovir Alafenamide as Salvage ART (NCT NCT02556333)

Last Updated: 2017-11-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

10 days

Results posted on

2017-11-14

Participant milestones
Measure	TAF Treatment 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 Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Emtricitabine/Tenofovir Alafenamide as Salvage ART

Baseline characteristics by cohort
Measure	TAF Treatment n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 10 days

Population: One patient with multiple drug resistant HIV infection enrolled into this study.

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.

Outcome measures
Measure	TAF Treatment n=1 Participants 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.
HIV RNA Change From Baseline to Day 10	0.01 log HIV RNA copies/mL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

National Institutes of Health, National Institute of Allergy and Infectious Diseases

Phone: 301-451-3740