NCT00594646

Brief Summary

This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Feb 2008

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

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

September 10, 2015

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

January 7, 2008

Results QC Date

August 10, 2015

Last Update Submit

October 4, 2022

Conditions

HIV Infections

Keywords

HIV PreventionNon-occupational post-exposure prophylaxisHIV seronegativity

Outcome Measures

Primary Outcomes (2)

  • Medication Regimen Completion Rates

    Pill counts performed at 14 and 28 days

    28 days

  • Number of HIV-1 Infected Participants

    Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected

    90 days

Study Arms (1)

Group 1

OTHER

TRUVADA

Drug: TRUVADA + Raltegravir

Interventions

TRUVADA + RaltegravirDRUG

TRUVADA (tenofovir disoproxil fumarate (DF) 300mg + emtricitabine 200mg) + RALTEGRAVIR 400mg

Also known as: tenofovir DF, emtricitabine
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV uninfected on the basis of a negative HIV Rapid Test, EIA or Western blot, and a negative HIV-1 RNA assay
  • Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.
  • Able to understand the study procedures and willing to sign informed consent

You may not qualify if:

  • Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
  • Pregnancy.
  • Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine therapy for hepatitis B.
  • Creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula.
  • Unwillingness to participate in study procedures, including Mental Health referral and intervention.
  • Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir.
  • Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Mayer KH, Mimiaga MJ, Gelman M, Grasso C. Raltegravir, tenofovir DF, and emtricitabine for postexposure prophylaxis to prevent the sexual transmission of HIV: safety, tolerability, and adherence. J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):354-9. doi: 10.1097/QAI.0b013e31824a03b8.

    PMID: 22267017RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationRaltegravir PotassiumTenofovirEmtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical PreparationsPyrrolidinonesPyrrolidines

Limitations and Caveats

Limitations of the current study included: 1. Reliance on self-reports to measure adherence 2. Study population almost exclusively male (reflecting the demographics of people who call Fenway Health's hotline after an acute sexual exposure)

Results Point of Contact

Title
Dr. Kenneth Mayer
Organization
Fenway Health
kmayer@fenwayhealth.org
617-927-6400

Study Officials

  • Kenneth H Mayer, MD

    Fenway Community Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, The Fenway Institute

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

August 1, 2010

Last Updated

October 25, 2022

Results First Posted

September 10, 2015

Record last verified: 2022-10

Locations

US(1)