NCT01902472

Brief Summary

This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4.2 years

First QC Date

July 15, 2013

Last Update Submit

July 10, 2020

Conditions

HIV

Keywords

HIV-1TruvadaFTC/TDFPre-exposure prophylaxisPrEPResistance

Outcome Measures

Primary Outcomes (3)

  • Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication

    Baseline to Year 3

  • Proportion of seroconverters with resistance mutations

    Baseline to Year 3

  • Proportion of seroconverters with signs/symptoms at or before seroconversion

    Baseline to Year 3

Study Arms (1)

FTC/TDF for PrEP

HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred fifty (150) HIV-1 negative adults (any sex/gender, including transgender) and ≥ 18 years of age who seroconvert while taking FTC/TDF for PrEP.

You may qualify if:

  • Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study
  • HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study.
  • Evidence of seroconversion while receiving FTC/TDF for PrEP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilead Sciences, Inc.

Foster City, California, 94404, United States

Location

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

September 2, 2013

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)