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NCT02519777 · ClinicalTrials.gov registry record · Phase 4
Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 191
- Enrollment target
NCT02519777: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02519777 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 191 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02519777, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 191 participants
- Enrollment target
Study Summary
People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral \[ARV\] medications) to participants' existing ART regimens improved participants' neurocognitive performance.
Primary Outcome
The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests: Domestic (US-based) and International Participants: * Grooved pegboard dominant * Grooved pegboard non-dominant * Hopkins Verbal Learning Test (HVLT-R) Learning trials * HVLT-R Delayed recall * HVLT-R Delayed recognition * Semantic verbal fluency Domestic only: * Stroop color naming * Stroop word reading * Stroop interference trial * Letter fluency * Trail M
Interventions
- DRUG Dolutegravir (DTG)
- DRUG Placebo for maraviroc (MVC)
- DRUG Placebo for dolutegravir (DTG)
- DRUG Maraviroc (MVC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2016-04-21 |
| Est. Completion | 2021-01-05 |
| Phase | Phase 4 |
What the finished NCT02519777 record still lists
NCT02519777 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 4 interventions - of which Dolutegravir (DTG) is the first listed.
NCT02519777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02519777 about?
NCT02519777 is a clinical study titled "Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)". People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral \[ARV\] medications) to participants' existing ART...
What is the current status of trial NCT02519777?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 191 participants. The study started on 2016-04-21. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT02519777?
The interventions under investigation include: Dolutegravir (DTG) (DRUG), Placebo for maraviroc (MVC) (DRUG), Placebo for dolutegravir (DTG) (DRUG), Maraviroc (MVC) (DRUG).
Who is sponsoring clinical trial NCT02519777?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02519777's enrollment target sits among peer trials
191 453rd of 2000 higher than 1,548 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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