Recruiting

Atripla to Stribild

Sponsor:

University of Hawaii

Code:

NCT02283060

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Stribild

Atripla

Study Details

Brief 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.

Conditions

HIV

Study ID

NCT02283060

Start date

Sep, 2014

Status verified date

Mar, 2016

Completion date

Aug, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • HIV infected
  • Age 18 to 65 years
  • On stable efavirenz/emtricitabine/tenofovir disoproxil fumarate regimen > 12 months
  • Documented plasma HIV RNA < 50 copies/ml within 3 months of entry
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Receipt of any other antiretroviral drugs in addition to efavirenz/emtricitabine/tenofovir disoproxil fumarate within 6 months of study entry
  • Any documented plasma HIV RNA > 100 copies/ml within the past 6 months prior to study entry
  • Chronic hepatitis B as assessed by positive hepatitis B surface antigen \[HBsAg\]
  • Chronic hepatitis C as assessed by positive hepatitis C antibody \[HCVab\], except with proof of viral clearance and normal liver function tests
  • Other chronic disease which is uncontrolled or likely to interfere with study results
  • Acute illness within 2 weeks of entry
  • Previously documented history of OSA (obstructive sleep apnea)
  • Moderate to high risk of OSA defined as BMI (Body mass index) > 30 plus two of the following: habitual snoring, gasping/choking, observed apnea while sleeping, neck circumference > 17 inches
  • Severe depression based on the BDI-2 (Beck Depression Inventory - II)
  • Chronic daily receipt of medications associated with potential for sleep interference (i.e. psychoactive drugs, steroids, decongestants, beta blockers)
  • Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
  • Anticipated need for medications which are contraindicated as per Stribild package insert
  • Any known contra-indication to use of Stribild (elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat)
  • Creatinine clearance (Cockcroft and Gault) < 70 ml/min
  • The following lab values:

1. Hemoglobin < 9.0
2. Absolute neutrophil count < 500/μL
3. Platelet count < 40,000/μL
4. AST (SGOT) and ALT (SGPT) > 5x ULN
  • Active or recent past history (within past 5 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements
  • Pregnancy or breast-feeding, intent to become pregnant during the course of the study or breast-feeding
  • Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Stribild switch arm

Patient to be taken off Atripla and switched to Stribild (co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) -one tablet taken daily with food

active comparator: Atripla control arm

Patient to continue taking Atripla (co-formulated efavirenz/emtricitabine/ tenofovir disoproxil fumarate) - one tablet taken daily at bedtime on an empty stomach

Interventions

Stribild

To be administered orally, once daily with food.

Atripla

To be administered orally, once daily at bedtime on an empty stomach

Primary outcome measure

  • Change in sleep architecture assessed by formal sleep study [ Time Frame: 12 weeks ]
  • Change in neuropsychological performance global and subdomain neuropsychological test scores [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Lorna Nagamine, RN

808-692-1333lornan@hawaii.edu

Locations

Hawaii Center for AIDS

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Lorna Nagamine

808-692-1333lornan@hawaii.edu

Debbie Ogata-Arakaki

808-692-1332ogataara@hawaii.edu

Principal Investigator:

Cecilia Shikuma, M.D.

More Information

Sponsor

University of Hawaii

Last update posted

Mar 14, 2016

Last verified

Mar, 2016

Keywords

  • Atripla
  • Stribild
  • HIV
  • Sleep architecture
  • Neuropsychological performance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2016-03-14.