The Neurocognitive Sub-study of Encore1
This study has been completed.
Sponsor:
Kirby Institute
Collaborator:
The HIV Netherlands Australia Thailand Research Collaboration
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01516060
First received: January 19, 2012
Last updated: September 18, 2013
Last verified: September 2013
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Purpose
The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Efavirenz |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Screening |
| Official Title: | The Neurocognitive Sub Study of Encore1:A Randomised, Double‐Blind, Placebo‐Controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus 2N(t)RTI in Antiretroviral‐naïve HIV‐Infected Individuals Over 96 Weeks A Randomised, Double-blind, Placebo-controlled, Clinical Trial to Compare the Safety and Efficacy of Reduced Dose Efavirenz (EFV) With Standard Dose EFV Plus Two Nucleotide Reverse Transcriptase Inhibitors (N(t)RTI) in Antiretroviral-naïve HIV-infected Individuals Over 96 Weeks |
Resource links provided by NLM:
Further study details as provided by Kirby Institute:
Primary Outcome Measures:
- The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- To assess dynamic changes in neurocognitive function over the total duration of follow-up. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 71 |
| Study Start Date: | January 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Reduced dose Efavirenz arm
Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).
|
Drug: Efavirenz
400mg qd; 2 x 200mg
|
|
Active Comparator: Normal Efavirenz dose arm
Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd)
|
Drug: Efavirenz
600mg qd; 3 x 200mg qd
|
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study.
Exclusion Criteria:
- Existing neurological brain disease
- Recent (<6months ) head injury
- Current major depression or psychosis
- Current alcohol abuse
- Intended use of recreational drugs during study period
- Uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516060
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516060
Locations
| Thailand | |
| HIVNAT Research Collaboration | |
| Bangkok, Thailand | |
Sponsors and Collaborators
Kirby Institute
The HIV Netherlands Australia Thailand Research Collaboration
Investigators
| Principal Investigator: | Rebekah Puls | Kirby Institute |
More Information
| Responsible Party: | Kirby Institute |
| ClinicalTrials.gov Identifier: | NCT01516060 History of Changes |
| Other Study ID Numbers: | Encore1-NC |
| Study First Received: | January 19, 2012 |
| Last Updated: | September 18, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee United Kingdom: National Institute for Health Research |
Additional relevant MeSH terms:
|
Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents |
Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on September 30, 2016