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Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV

NCT00949234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2017-12-18

Study results available
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Summary

The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.

Conditions

  • HIV Prevention
  • HIV Infections

Interventions

DRUG

tenofovir + emtricitabine, lopinavir/ritonavir

The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance \<30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen: Preferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily

Sponsors & Collaborators

  • Los Angeles County Department of Public Health

    collaborator OTHER_GOV

  • AIDS Project Los Angeles

    collaborator OTHER

  • Los Angeles LGBT Center

    collaborator OTHER

  • The OASIS Clinic

    collaborator UNKNOWN

  • University of California, Los Angeles

    lead OTHER

Principal Investigators

  • Raphael J. Landovitz, M.D. · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-06-30
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949234 on ClinicalTrials.gov