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

Primary Purpose

HIV Prevention, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tenofovir + emtricitabine, lopinavir/ritonavir
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Prevention focused on measuring post exposure prophylaxis, biomedical prevention, HIV seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • Able to understand and provide consent
  • High-Risk Exposure Characteristic

  • (one or more of the below, unprotected or with failed condom use)

    • Receptive Anal Intercourse
    • Insertive Anal Intercourse
    • Receptive Vaginal Intercourse
    • Insertive Vaginal Intercourse

  • Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below)

    • Sharing injection drug works which have been intravascular

  • High-Risk Source (one or more of the below)

    • Known HIV positive
    • MSM
    • MSM/W
    • IDU
    • CSW
    • Sexual perpetrator
    • From an endemic country (prevalence >1%)
    • Partner of one of the above
  • Exposure within 72 hours of presentation
  • Not known to be HIV positive
  • No countermanding concomitant medications or allergies
  • HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).

Exclusion Criteria:

  • Patients <18 years of age
  • Unable to understand and provide consent
  • Exposure >72 hours of presentation
  • Known to be HIV positive
  • Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms

  • Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including

    • adherence to PEP medication dosing
    • Demonstrated HIV-positive on rapid testing
    • Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure
    • Unwillingness of breast-feeding women to transition to formula feeding

Sites / Locations

  • L.A. Gay & Lesbian Center
  • OASIS Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-Label

Arm Description

This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.

Outcomes

Primary Outcome Measures

Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit

Secondary Outcome Measures

Full Information

First Posted
July 29, 2009
Last Updated
December 15, 2017
Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health, AIDS Project Los Angeles, Los Angeles LGBT Center, The OASIS Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00949234
Brief Title
Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Official Title
A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health, AIDS Project Los Angeles, Los Angeles LGBT Center, The OASIS Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care. In its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, HIV Infections
Keywords
post exposure prophylaxis, biomedical prevention, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label
Arm Type
Other
Arm Description
This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.
Intervention Type
Drug
Intervention Name(s)
tenofovir + emtricitabine, lopinavir/ritonavir
Other Intervention Name(s)
Truvada, Combivir
Intervention Description
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
Primary Outcome Measure Information:
Title
Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be at least 18 years of age Able to understand and provide consent High-Risk Exposure Characteristic (one or more of the below, unprotected or with failed condom use) Receptive Anal Intercourse Insertive Anal Intercourse Receptive Vaginal Intercourse Insertive Vaginal Intercourse Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source (supersedes all "high-risk source" criteria below) Sharing injection drug works which have been intravascular High-Risk Source (one or more of the below) Known HIV positive MSM MSM/W IDU CSW Sexual perpetrator From an endemic country (prevalence >1%) Partner of one of the above Exposure within 72 hours of presentation Not known to be HIV positive No countermanding concomitant medications or allergies HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments). Exclusion Criteria: Patients <18 years of age Unable to understand and provide consent Exposure >72 hours of presentation Known to be HIV positive Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms Any condition, which in the opinion of the intake provider, will seriously compromise the patient's ability to comply with the protocol, including adherence to PEP medication dosing Demonstrated HIV-positive on rapid testing Unwillingness to commit to barrier-method (male and/or female condom) use until HIV-negative-status is confirmed 6 months after exposure Unwillingness of breast-feeding women to transition to formula feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael J. Landovitz, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
L.A. Gay & Lesbian Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
OASIS Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States

12. IPD Sharing Statement

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

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