A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services

NCT01781806 | Completed Phase 4 Results FDA Drug

• 1 other identifier: EI11-LA-002
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Grade 2 or Higher Adverse Event by Cohort

  Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.

  Baseline to 48 weeks

Secondary Outcomes (1)

• Cohort H PrEP Engagement by Study Visit

  Baseline to 48 weeks

Other Outcomes (2)

• Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline

  Baseline to 48 weeks

• Number of HIV Seroconversions by Cohort.

  Baseline to 48 weeks

Study Arms (2)

Cohort H (PrEP)

ACTIVE COMPARATOR

Participants in the H cohort will be provided with a CPP, including daily oral emtricitabine/tenofovir-based PrEP. High Risk Cohort Criteria (one or more of the following has to be met): 1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months. 2. STD diagnosis during the last 12 months. 3. Previous PEP use during the last 12 months (\* see exclusion criteria) 4. Has at least one HIV infected sexual partner for ≥4 weeks.

Drug: emtricitabine 200mg/tenofovir 300mg

Cohort LM (PEP)

ACTIVE COMPARATOR

Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.

Drug: emtricitabine 200mg/tenofovir 300mg

Interventions

emtricitabine 200mg/tenofovir 300mg DRUG

The intervention medication 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 a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl \<30 mL/min, Truvada will be discontinued.

Also known as: Truvada

Cohort H (PrEP); Cohort LM (PEP)

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Able to understand and provide consent in English or Spanish
• Self identified MSM, MSM/W, or Transfemale
• At least one male sex partner for anal intercourse in the prior 12 months
• HIV negative by enzyme immunoassay (EIA) and viral load (VL)
• CrCl ≥ 60 ml/min (via Cockcroft-Gault formula)
• No signs or symptoms suggestive of primary HIV infection (PHI).

You may not qualify if:

• Participants \<18 years of age
• Unable to understand and provide consent in English or Spanish
• Known or found on testing to be HIV positive
• Any condition, which in the opinion of the intake provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PEP or PrEP medication dosing
• Use of Antiretroviral therapy (ART) taken for any indication (i.e. PEP or PrEP) within 60 days of study entry
• Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
• Signs or symptoms suspicious for PHI.

Sponsors & Collaborators

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

Study Sites (2)

L.A. Gay and Lesbian Center

Los Angeles, California, 90028, United States

Location

The OASIS Clinic

Los Angeles, California, 90059, United States

Location

MeSH Terms

Interventions

Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

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

rlandovitz@mednet.ucla.edu

(310) 825-6689

Study Officials

• Raphael Landovitz, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: February 1, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 6, 2018
• Results First Posted: September 20, 2017

Record last verified: 2018-04

Locations

US (2)