Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

NCT02477527 | Completed Phase 4 Results

• 1 other identifier: EB001JP001
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Conditions

HIV; AIDS; Sleep Disorders

Keywords

atripla; stribild; dreams

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Viral Loads < 50 Following the Switch

  percentage of patients with viral loads \< 50 following the switch at 24 weeks.

  24 weeks

Secondary Outcomes (3)

• T-cell Changes

  24 weeks

• Improvements in Central Nervous System Toxicity Score

  24 weeks

• Improvements in Sleep Disorder Score

  24 weeks

Other Outcomes (1)

• Safety as Measured by Side Effects

  24 weeks

Study Arms (1)

Stribild

EXPERIMENTAL

Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.

Drug: Stribild

Interventions

Stribild DRUG

Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.

Stribild

Eligibility Criteria

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

You may qualify if:

• HIV+ subjects 18 years of age or older
• estimated Glomerular Filtration Rate \> 70 mL/min
• must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load \< 50 copies/mL
• no antiretrovirals prior to the initiation of Atripla
• baseline genotyping

You may not qualify if:

• pregnancy
• unable to provide informed consent
• enrolled in another study

Sponsors & Collaborators

• Midtown Medical Center, Tampa, FL: lead
• Gilead Sciences: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sleep Wake Disorders

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Edward W Braun, MD
• Organization: Midtown Medical Center

Dr.Braun@DrEdwardBraun.com

8139353221

Study Officials

• Edward W Braun, MD

  Midtown Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 22, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 28, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share