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InfectionPhase 3PERIEPNCT01697046

A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection

A Phase 3 study testing Truvada and Isentress in people with Infection and HIV, run by Projeto Praça Onze at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This will be a pilot, open label study involving 65 participants. All participants will be followed until seroconversion or until the last enrolled participant completes one year of follow-up, whichever happens first. Participant study number will be given at the screening visit, prior to inclusion in the study. 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
Infection, HIV
What is being tested?
Truvada and Isentress
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteBrazil
Study dates
Nov 2012to Mar 2014
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Individuals will be included in the clinical trial if they meet ALL of the following criteria:
  • Male sex (at birth);
  • Willing and able to provide written informed consent;
  • Age 18 years or older;
  • HIV-1-uninfected;
  • Absence of signs or symptoms compatible with an acute viral disease
Show all 9Show fewer
  • Evidence of high risk for acquiring HIV-1 infection including any one of the following: 1) No condom use during the last receptive and/or insertive anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 4 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used.
  • Adequate renal function
  • Adequate hepatic function

Who cannot join

  • Glycosuria or proteinuria
  • Acute hepatitis B infection
  • History of pathological bone fractures not related to trauma
  • Active alcohol or drug use considered sufficient to hinder compliance with any study procedures
  • 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 study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives

Trial locations and contacts

1 site in 1 country.

Monica Barbosa de Souza, BA contact

+55 21 22739073 ext. 14

monica@ponze.ufrj.br

Carina Beppu Yoshida, RN contact

+55 21 22739073 ext. 15

carina@ponze.ufrj.br

Brazil1 site

  • Monica Barbosa de Souza

    Rio de Janeiro, Rio de Janeiro, 20210-030

    Carina Beppu Yoshida, RN, +55 21 22739073 ext. 15, carina@ponze.ufrj.br

    Rafael Quaresma Garrido, MD

Other trials in Brazil

About this study

Official title: A Pilot Study of the Safety, Acceptability, Behavior Impact, and HIV Seroincidence Among High Risk Men Who Have Sex With Men With Access to Isentress 400 mg BID + Truvada Once Daily for Peri-exposure Chemoprophylaxis for HIV Infection Chemoprophylaxis for HIV Infection

This will be a pilot, open label study involving 65 participants. All participants will be followed until seroconversion or until the last enrolled participant completes one year of follow-up, whichever happens first. Participant study number will be given at the screening visit, prior to inclusion in the study.

The chosen intervention and study regimen are based on the dynamics of viral infection and the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside and nucleotide analogues need to be phosphorylated intracellularly. On the other hand, available data indicate that it takes approximately 10 hours between exposure and HIV viral integration, offering a window of opportunity for Raltegravir to block integration and thus prevent infection, given that this drug does not need to be metabolized to exert its effect. The intervention will be maintained for 4 weeks following exposure, in accordance with Brazilian and CDC guidelines for PEP.

Read the detailed description

Subjects with reported high-risk behavior (and anticipated future high-risk behavior) but no exposure in the immediate past will be the focus of this study.

Participants will be prescribed raltegravir 400 mg BID + Truvada once daily. All study participants will receive a 4-days starter pack. Study participants will be instructed to start study drugs if they expect or experience an exposure of any mucous membrane (oral, urethral, anal) to semen. Subjects who expect or experience these exposures will be instructed to take 1 pill of Raltegravir 400mg and one pill of truvada, followed by a second dose of Raltegravir 12 hours later. From the second day onward, participants will be instructed to take Raltegravir 400 mg BID + Truvada once daily. The first dose should be taken no more than 6 hours before or 6 hours after the expected or actual exposure and continued for 28 days.

Enrolled subjects will also be instructed to report to the study site within 4 days of beginning study drugs to respond to a CASI questionnaire and to have blood taken. They will be instructed to return at the end of the 4-week chemoprophylaxis course for reevaluation and to be given another 4-day supply of medication. Under no circumstances will any participant be given a greater than 4 week supply of medication; all will be evaluated for toxicity and adherence following each course of chemoprophylaxis.

The study participants will be monitored closely for safety after each course of chemoprophylaxis and at the end of the trial. In addition, subjects will be instructed to immediately contact the site if they experience certain symptoms consistent with severe toxicity. At each evaluation a careful clinical history, physical examination, and laboratory assessment, including HIV serology, will be completed. Adherence will be estimated based on self-report and the use of pill counts. During each visit, subjects will be reminded of the need to not increase high-risk sexual behavior. HIV serology and response to a CASI questionnaire will be conducted monthly.

Conditions
Infection, HIV
Being tested
Truvada and Isentress
Keywords
peri-exposure, chemoprophylaxis
Medical subject headings
Infections

What participants receive

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

  • Truvada and IsentressDrug

    Subjects with reported high-risk behavior (and anticipated future high-risk behavior) but no exposure in the immediate past will be the focus of this study.

    Participants will be prescribed raltegravir 400 mg BID + Truvada once daily. All study participants will receive a 4-days starter pack. Study participants will be instructed to start study drugs if they expect or experience an exposure of any mucous membrane (oral, urethral, anal) to semen. Subjects who expect or experience these exposures will be instructed to take 1 pill of Raltegravir 400mg and one pill of truvada, followed by a second dose of Raltegravir 12 hours later. From the second day onward, participants will be instructed to take Raltegravir 400 mg BID + Truvada once daily. The first dose should be taken no more than 6 hours before or 6 hours after the expected or actual exposure and continued for 28 days.

Study groups in NCT01697046
Study groupRoleWhat they receive
Isentress+TruvadaExperimentalAll participants will receive the intervention
Receives: Drug: Truvada and Isentress

What is being measured

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

  1. Safety

    Number and severity of adverse events

    Measured: 16 months

Secondary outcomes (1)

  1. HIV seroincidence

    Rate of incidence of new infections

    Measured: 16 months

Timeline

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

  1. First posted2 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMar 2014 (estimated)
  4. Study completionMar 2014 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01697046
Sponsor's protocol ID
IIS# 39550
Acronym
PERIEP
Status last verified
Sep 2012
First submitted
24 Sep 2012
Last updated
2 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • Centers for Disease Control and Prevention (CDC). Update: provisional Public Health Service recommendations for chemoprophylaxis after occupational exposure to HIV. MMWR Morb Mortal Wkly Rep. 1996 Jun 7;45(22):468-80.

    PubMed 8622618

  • Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D, Heptonstall J, Ippolito G, Lot F, McKibben PS, Bell DM. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med. 1997 Nov 20;337(21):1485-90. doi: 10.1056/NEJM199711203372101.

    PubMed 9366579

  • Schechter M, do Lago RF, Mendelsohn AB, Moreira RI, Moulton LH, Harrison LH; Praca Onze Study Team. Behavioral impact, acceptability, and HIV incidence among homosexual men with access to postexposure chemoprophylaxis for HIV. J Acquir Immune Defic Syndr. 2004 Apr 15;35(5):519-25. doi: 10.1097/00126334-200404150-00010.

    PubMed 15021317

  • Grant, RM; Lama, JR; Anderson, PL; McMahan, V; Liu, AY; Vargas, L; Goicochea, P; Casapía, M; Guanira-Carranza, JV; Ramirez-Cardich, ME; Montoya-Herrera,O; Fernandez, T; Veloso, VG; Buchbinder, SP; Chariyalertsak, S; Schechter, M; Gail -Bekker, L; Mayer, KM; Kallas, EG; Amico, KR; Mulligan, K; Bushman, LR; Hance, TJ; Ganoza, C; Defechereux, P; Brian, P; Wang, F; McConnell, JJ; Zheng, JH; Lee, J; Rooney, JF; Jaffe, HS; Martinez, AI; Burns, DN; Glidden, DV. Pre-Exposure Chemoprophylaxis for HIV Prevention in Men who Have Sex with Men. New Eng J Med 2010; 363:2587-99.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Truvada and Isentress in people with Infection and HIV, run by Projeto Praça Onze at 1 site in Brazil.

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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Monica Barbosa de Souza, BA (+55 21 22739073 ext. 14, monica@ponze.ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 16 months). 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 NCT01697046, which also lists 4 linked publications.

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 2 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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