The Neurocognitive Sub-study of Encore1
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ClinicalTrials.gov Identifier: NCT01516060 |
Recruitment Status
:
Completed
First Posted
: January 24, 2012
Last Update Posted
: September 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Efavirenz | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
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).
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Drug: Efavirenz
400mg qd; 2 x 200mg
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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)
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Drug: Efavirenz
600mg qd; 3 x 200mg qd
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- The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV [ Time Frame: 48 weeks ]
- The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24. [ Time Frame: Week 24 ]
- To assess dynamic changes in neurocognitive function over the total duration of follow-up. [ Time Frame: 96 weeks ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516060
Thailand | |
HIVNAT Research Collaboration | |
Bangkok, Thailand |
Principal Investigator: | Rebekah Puls | Kirby Institute |
Responsible Party: | Kirby Institute |
ClinicalTrials.gov Identifier: | NCT01516060 History of Changes |
Other Study ID Numbers: |
Encore1-NC |
First Posted: | January 24, 2012 Key Record Dates |
Last Update Posted: | September 19, 2013 |
Last Verified: | September 2013 |
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 |