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NCT Number: NCT02477527

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stribild

Drug

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

Primary outcomes

  1. Percentage of Patients With Viral Loads < 50 Following the Switch

    Time frame: 24 weeks

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

Secondary outcomes

  1. T-cell Changes

    Time frame: 24 weeks

    Change in CD4 Cell count from baseline to 24 weeks.

  2. Improvements in Central Nervous System Toxicity Score

    Time frame: 24 weeks

    Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale.

    The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for "None", 1 for "Mild", 2 for "Moderate" and 3 for "Severe". The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures.

  3. Improvements in Sleep Disorder Score

    Time frame: 24 weeks

    Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.

Other outcomes

  1. Safety as Measured by Side Effects

    Time frame: 24 weeks

    Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.

Sponsors and collaborators

Lead sponsor

Midtown Medical Center, Tampa, FL

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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