HIV Non-Occupational Post-Exposure Prophylaxis (QUAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01855867|
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV Open-label Evaluation of Safety, Tolerability and Acceptability of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate Single-tablet Regimen for Non-occupational Prophylaxis Following Potential Exposure to HIV-1|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2016|
Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg) taken for 28 days, within 72 hours of a possible sexual exposure to HIV
Drug: Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)
- Safety and Tolerability - as measured by number of participants with adverse events, the severity of adverse events and frequency of adverse events [ Time Frame: Day 0, 14, 30 and 90 ]Safety and tolerability will be measured by laboratory testing and clinical review of systems. Blood will be collected, via phlebotomy, at day 0, 30 and 90. Laboratory testing will include: CBC with differential, ALT, AST, total bilirubin, creatinine, BUN and hepatitis B at day 0. HIV testing will be done, by finger stick, at day 0, 30 and 90 - with confirmation testing if rapid testing indicates a reactive result or if acute seroconversion is suspected. HIV antigen testing will be conducted, via venipuncture, at day 90. Clinic staff will query participants on health status at day 0 and changes to their health on day 14, 30 and 90. If indicated, targeted physical exams will be offered. Adverse events, which are deemed related to the study intervention, will be followed until considered resolved or sequelae are considered permanent. Negative social impacts, due to study participation, will also be monitored from day 0 to day 90.
- Awareness and attitudes around non-occupational post-prophylaxis [ Time Frame: Day 14 and Day 90 ]To describe awareness and attitudes around nPEP among persons presenting for nPEP after a high-risk sexual contact, at day 14 and day 90. Perceptions will be collected by a computer based survey.
- Awareness and attitudes around HIV pre-exposure prophylaxis [ Time Frame: Day 14 and Day 90 ]To describe awareness and attitudes around PrEP among persons presenting for NPEP after a high-risk sexual contact, at Day 14 and Day 90. Perceptions will be collected by a computer based survey.
- Adherence compared to other nPEP regimens studied at Fenway Health or from literature review. [ Time Frame: Day 14 and 30 ]To compare adherence rates, based on self-reported missed doses and pill count with the investigational regimen, with historical adherence rates for NPEP regimens. Adherence will be measured by participant self report and pill count done at the clinic.
- Description of nPEP failure (HIV infection during study participation) [ Time Frame: Day 0 through 90 ]Instances of NPEP failure (i.e., incident HIV infections during the study period) will be identified by HIV testing and stored plasma samples analysis collected at Day 0, 30 and 90. Additionally, HIV testing will be done if the participant presents or reports signs and/or symptoms of HIV seroconversion (i.e. fever, body aches, chills, rash). If available a description of the clinical status and disease state of the source individual will be developed. Additionally, characterization will be made of the infecting virus genotypically from both the infected subject and, if possible, from the source individual.
- Safety, measured by number of participants that report adverse events and the associated severity, compared to other nPEP regimens studied at Fenway Health or from literature review. [ Time Frame: Day 0, 14, 30, 90 ]To compare the safety profile, developed from adverse events and severity, of Elivitegravir / Combicistat / Emtricitabine / Tenofovir Disoproxil Fumarate with other NPEP regimens and other Truvada containing regimens used in historical control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855867
|United States, Massachusetts|
|Fenway Community Health|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Kenneth H. Mayer, MD||The Fenway Institute, Fenway Community Health|