HIV InfectionsNCT01632995

Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics

A study testing FTC 200 mg/TDF 300 mg fixed-dose combination tablet in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center… Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: FTC 200 mg/TDF 300 mg fixed-dose combination tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 557 participants
Where: 3 sitesUnited States
Study dates: Oct 2012to Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must be either a man who has sex with men or a transgender female
Male sex (at birth)
Willing and able to provide written informed consent
HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening
No laboratory evidence of a detectable HIV viral load (San Francisco site only)
Evidence of risk of acquiring HIV-1 infection including any one of the following:

Show all 11Show fewer

Condomless anal sex with two or more male or transgender female sex partners during the last 12 months; or (2) two or more episodes of anal sex with at least one HIV-positive partner during the last 12 months; or (3) sex with a male or transgender female partner and any of the following STDs diagnosed during the last 12 months or at screening: syphilis, rectal gonorrhea, or rectal chlamydia.
Able to provide a street address of residence or phone number for themselves or two personal contacts who would know their whereabouts during the period of the demonstration project
Adequate renal function: creatinine clearance of 60 ml/min or greater as estimated by the Cockcroft-Gault equation within 45 days of enrollment
A urine dipstick with a negative or trace result for protein within 45 days of enrollment
Fluent in English or in Spanish

Who cannot join

Signs or symptoms of acute HIV infection
Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment
Hepatitis B surface antigen (HBsAg) positive
History of pathological bone fractures not related to trauma
Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Miami PrEP Non-Network CRS
Miami, Florida, 33136
SF City Clinic Non-Network CRS
San Francisco, California, 94103
Whitman Walker Non-network CRS
Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

Official title: Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project

Read the detailed description

A previous study (iPrEx) showed that daily PrEP with FTC/TDF provided with a comprehensive package of prevention services is effective in preventing HIV infection among men who have sex with men (MSM). The PrEP administered in that study was given in the context of a research setting/controlled trial, but it is important to evaluate the acceptability, sustainability, and safety of PrEP in a "real world" setting. This study will evaluate PrEP administered to HIV-uninfected MSM and transgender females at two STD clinics and one community health center in the United States.

Each participant will receive PrEP for up to 1 year and will have up to 8 study visits. PrEP will consist of one fixed-dose FTC/TDF combination tablet orally each day. All participants will have study visits at screening, enrollment, and 4 weeks after enrollment; participants will continue to have visits at Weeks 12, 24, 36, 48, and 52 if they do not seroconvert. Participants who seroconvert will discontinue PrEP and will have a post-drug discontinuation visit 4 weeks after discontinuing PrEP. At most visits, participants will undergo blood, urine, and hair sample collection; give a medical history; undergo a physical exam; receive risk-reduction counseling and condoms; undergo testing for HIV and other STDs; receive study drugs; and undergo a pill count and adherence assessment (follow-up visits only). For participants who stop taking the study drug but remain in the study, urine, blood, and hair samples will not be collected at 12-week follow-up visits if all stop procedures have been completed and if there are no lab abnormalities that require additional follow-up. Participants will also answer questionnaires at screening, 12-week visits, and at study exit.

Conditions: HIV Infections
Being tested: FTC 200 mg/TDF 300 mg fixed-dose combination tablet
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FTC 200 mg/TDF 300 mg fixed-dose combination tabletDrug
Also called Truvada
Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.

Study groups in NCT01632995
Study group	Role	What they receive
Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)	Experimental	All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day. Receives: Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Acceptance Rate of PrEP
Measured: Measured through enrollment (Week 0)
Measurement of Refusal Rate of PrEP
Measured: Measured through enrollment (Week 0)
Duration of PrEP Use
Number of study drug interruptions
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Duration of PrEP Use
Mean duration of interruptions
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of Side Effects/Toxicities
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by TFV-DP Levels in DBS
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Number of Male Sexual Partners
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by Medication Possession Ratio
Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits
Measured: Participants were followed for 48 weeks, or up to the point of early termination

Secondary outcomes (2)

Number of Participants Who Seroconvert
Measured: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected
Measured: Participants were followed for 48 weeks, or up to the point of early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Feb 2015

First posted4 Jul 2012 (estimated)
Study startOct 2012
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 557 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01632995
Sponsor's protocol ID: PrEP Demonstration Project
Other IDs: 11879
Status last verified: Jul 2016
First submitted: 29 Jun 2012
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PubMed 21091279

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project
ClinicalTrials.gov ID: NCT01632995
Acronym / sponsor ID: PrEP Demonstration Project
Conditions: HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 557 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Oct 2012
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 4 Jul 2012 (estimated)
Results: Posted 21 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)	Experimental	Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tabletAll study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Must be either a man who has sex with men or a transgender female
Male sex (at birth)
Willing and able to provide written informed consent
HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening
No laboratory evidence of a detectable HIV viral load (San Francisco site only)

Key exclusion criteria (7 listed)

Signs or symptoms of acute HIV infection
Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment
Hepatitis B surface antigen (HBsAg) positive
History of pathological bone fractures not related to trauma
Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FTC 200 mg/TDF 300 mg fixed-dose combination tabletAlso: TruvadaEach participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.	Drug	Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)

Primary outcome

Measurement of Acceptance Rate of PrEP
Time frame: Measured through enrollment (Week 0)
Measurement of Refusal Rate of PrEP
Time frame: Measured through enrollment (Week 0)
Duration of PrEP Use
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Number of study drug interruptions
Duration of PrEP Use
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Mean duration of interruptions
Measurement of Side Effects/Toxicities
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by TFV-DP Levels in DBS
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Number of Male Sexual Partners
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by Medication Possession Ratio
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits

2 secondary outcomes

Number of Participants Who Seroconvert
Time frame: Participants were followed for 48 weeks, or up to the point of early termination
Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected
Time frame: Participants were followed for 48 weeks, or up to the point of early termination

Results and safety

Results posted to the registry on 21 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)	1,069	557

Primary outcome: Measurement of Acceptance Rate of PrEP

Time frame: Measured through enrollment (Week 0). Count of participants. Unit: Participants

Measure	Participants Assessed for Participation n = 1069
Potentially eligible clients	921
Participants enrolled	557

Primary outcome: Measurement of Refusal Rate of PrEP

Time frame: Measured through enrollment (Week 0). Count of participants. Unit: Participants

Measure	Participants Assessed for Participation n = 1069
Potentially eligible clients	921
Declined participation	364

Primary outcome: Duration of PrEP Use

Time frame: Participants were followed for 48 weeks, or up to the point of early termination. Number. Unit: interruptions

Measure	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) n = 557
Value	86

Primary outcome: Duration of PrEP Use

Time frame: Participants were followed for 48 weeks, or up to the point of early termination. Number. Unit: Days

Measure	Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) n = 557
Value	65

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)	19 of 557 (3.4%)	25 of 557 (4.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21091279Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Albert Liu, MD, MPH study chair

San Francisco Department of Public Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FTC 200 mg/TDF 300 mg fixed-dose combination tablet in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Acceptance Rate of PrEP (time frame: Measured through enrollment (Week 0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632995, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.