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

NCT00949234 | Completed Phase 2 Results DMC

• 1 other identifier: PQUAD
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention; HIV Infections

Keywords

post exposure prophylaxis; biomedical prevention; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

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

  24 Weeks

Study Arms (1)

Open-Label

OTHER

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

Drug: tenofovir + emtricitabine, lopinavir/ritonavir

Interventions

tenofovir + emtricitabine, lopinavir/ritonavir DRUG

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

Also known as: Truvada, Combivir

Open-Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Los Angeles County Department of Public Health: collaborator
• AIDS Project Los Angeles: collaborator
• Los Angeles LGBT Center: collaborator
• The OASIS Clinic: collaborator

Study Sites (2)

L.A. Gay & Lesbian Center

Los Angeles, California, 90028, United States

Location

OASIS Clinic

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Lopinavir; Ritonavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; lamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrimidinones; Thiazoles; Sulfur Compounds; Azoles; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Open label clinical trial of deploying PEP regimens at community based sites. Non-randomized and guidelines have subsequently evolved.

Results Point of Contact

• Title: Dr. Raphael Landovitz
• Organization: UCLA CARE Center

rlandovitz@mednet.ucla.edu

310-557-1891

Study Officials

• Raphael J. Landovitz, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE)

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2011
• Last Updated: December 18, 2017
• Results First Posted: December 18, 2017

Record last verified: 2017-12

Locations

US (2)