Trial Outcomes & Findings for Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals (NCT NCT02621242)

Last Updated: 2024-07-12

Results Overview

Global transcriptome analysis tests for expression changes of any possible gene across the entire human genome in response to Truvada PrEP. The main outcome of such an analysis is the number of genes significantly changing in expression between before and after treatment. We will report that Truvada PrEP up-regulates X number of genes and down-regulates Y number of genes.

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

2-3 months after initiating HIV Pre-exposure prophylaxis

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort All subjects will undergo all procedures Upper endoscopy: Upper endoscopy with biopsies Anoscopy: Anoscopy with biopsies Truvada: Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort n=9 Participants All subjects will undergo all procedures Upper endoscopy: Upper endoscopy with biopsies Anoscopy: Anoscopy with biopsies Truvada: Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 months after initiating HIV Pre-exposure prophylaxis

Population: Duodenal biopsies

Outcome measures

Outcome measures
Measure	Cohort n=16321 Genes All subjects will undergo all procedures Upper endoscopy: Upper endoscopy with biopsies Anoscopy: Anoscopy with biopsies Truvada: Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.
Global Transcriptome Analysis Up-regulated	116 genes
Global Transcriptome Analysis Down-regulated	135 genes

Adverse Events

Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanne Stekler

University of Washington

Phone: 206-744-8312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place