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Antiretroviral

Stribild switch arm for HIV/AIDS

Phase 4
Waitlist Available
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV infected
Age 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral medications given for the treatment of HIV. Both drugs are reasonably well tolerated. However, efavirenz, a component of Atripla, is known to cause "mental" side effects. This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep and cognition may represent the best option to determine whether use of efavirenz is associated with effects on sleep and cognition beyond the immediate period following initiation of drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in neuropsychological performance global and subdomain neuropsychological test scores
Change in sleep architecture assessed by formal sleep study
Secondary outcome measures
Change in Pittsburgh Sleep Quality Index Score
Change in the frequency of use of sleep medications
Change in the quality of life index score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Stribild switch armExperimental Treatment1 Intervention
Patient to be taken off Atripla and switched to Stribild (co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) -one tablet taken daily with food
Group II: Atripla control armActive Control1 Intervention
Patient to continue taking Atripla (co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate) - one tablet taken daily at bedtime on an empty stomach
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elvitegravir
FDA approved

Find a Location

Who is running the clinical trial?

University of HawaiiLead Sponsor
114 Previous Clinical Trials
54,599 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025