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Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified November 2010

Sponsor
University of California, Los Angeles

Collaborator
Los Angeles County Department of Public Health
AIDS Project Los Angeles
Los Angeles LGBT Center
OASIS Clinic

Information provided by (Responsible Party)
University of California, Los Angeles
ClinicalTrials.gov Identifier
NCT00949234

First received: July 29, 2009
Last updated: November 30, 2010
Last Verified: November 2010
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Transmission
HIV Infections

Drug : tenofovir + emtricitabine, lopinavir/ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures

  • To provide a comprehensive package of HIV prevention services, of which PEP can be an integral component.
Secondary Outcome Measures:
  • To evaluate the acceptability, feasibility, and safety of administering PEP in easily acceptable, non-judgmental, culturally, ethnically and linguistically appropriate environments.

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949234

Locations

United States, California
L.A. Gay & Lesbian Center Recruiting
Los Angeles, California, United States, 90028
Contact: Dustin Kerrone    323-993-7571
OASIS Clinic Recruiting
Los Angeles, California, United States, 90059
Contact: Collins Nwadiogbu    310-668-6038

Sponsors and Collaborators

University of California, Los Angeles
Los Angeles County Department of Public Health
AIDS Project Los Angeles
Los Angeles LGBT Center
OASIS Clinic

Investigators

Principal Investigator: Raphael J. Landovitz, M.D. University of California, Los Angeles
More Information

More Information


Responsible Party: Raphael J. Landovitz, M.D., University of California, Los Angeles  
ClinicalTrials.gov Identifier: NCT00949234   History of Changes  
Other Study ID Numbers: PQUAD  
Study First Received: July 29, 2009  
Last Updated: November 30, 2010  

Keywords provided by University of California, Los Angeles:

post exposure prophylaxis
biomedical prevention
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine, zidovudine drug combination

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.