Phase 4 N=27 Treatment

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

HIV · AIDS · Sleep Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02477527 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Percentage of Patients With Viral Loads < 50 Following the Switch — 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Stribild (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Midtown Medical Center, Tampa, FL
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Viral Loads < 50 Following the Switch	20	—
SECONDARY T-cell Changes	151	—
SECONDARY Improvements in Central Nervous System Toxicity Score	2.0	—
SECONDARY Improvements in Sleep Disorder Score	-4	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02477527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.