Phase 4
Completed N=27
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Source: ClinicalTrials.gov NCT02477527 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Patients With Viral Loads < 50 Following the Switch — 20 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
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 | — |
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
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. Informational only — not medical advice.