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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Los Angeles County Office of AIDS Programs and Policy
AIDS Project Los Angeles (APLA)
Los Angeles Gay and Lesbian Center
OASIS Clinic
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00949234
First received: July 29, 2009
Last updated: November 30, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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)
Intervention Details:
    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

    Other Names:
    • Truvada
    • Combivir
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
OASIS Clinic Recruiting
Los Angeles, California, United States, 90059
Contact: Collins Nwadiogbu    310-668-6038      
L.A. Gay & Lesbian Center Recruiting
Los Angeles, California, United States, 90028
Contact: Dustin Kerrone    323-993-7571      
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles County Office of AIDS Programs and Policy
AIDS Project Los Angeles (APLA)
Los Angeles Gay and Lesbian Center
OASIS Clinic
Investigators
Principal Investigator: Raphael J. Landovitz, M.D. University of California, Los Angeles
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
post exposure prophylaxis
biomedical prevention
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Lamivudine, zidovudine drug combination
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014