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Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Information source: Midtown Medical Center, Tampa, FL
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; AIDS; Sleep Disorders

Intervention: elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Midtown Medical Center, Tampa, FL

Official(s) and/or principal investigator(s):
Edward W Braun, MD, Principal Investigator, Affiliation: Midtown Medical Center

Summary

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

Clinical Details

Official title: Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: percentage of patients with viral loads < 50 following the switch

Secondary outcome:

T-cell changes

improvements in Central Nervous System toxicity score

improvements in sleep disorder score

Detailed description: Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- pregnancy

- unable to provide informed consent

- enrolled in another study

Locations and Contacts

Additional Information

Starting date: February 2015
Last updated: June 19, 2015

Page last updated: August 23, 2015

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