Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)
NCT02519777, Phase 4, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-03-02
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND) | ClinicalTrials.gov |
| NCT number | NCT02519777 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 191 participants, actual | ClinicalTrials.gov |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ClinicalTrials.gov |
| Conditions | HIV Infections | ClinicalTrials.gov |
| Interventions | Placebo for maraviroc (MVC), Placebo for dolutegravir (DTG), Dolutegravir (DTG), Maraviroc (MVC) | ClinicalTrials.gov |
| First posted | 2015-08-11 | ClinicalTrials.gov |
| Last updated | 2022-04-22 | ClinicalTrials.gov |
| Results first posted | 2022-03-02 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline | Measured at Baseline and Week 48 | 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 Making A * Trail Making B * WAIS-III Symbol search * Digit Symbol International only: * Timed Gait * Finger Tapping Dominant * Finger Tapping Non-dominant * Color Trail 1 Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at Week 48 minus the total z-score at Baseline. | ClinicalTrials.gov |
| Secondary | Number of Participants With Treatment Related Adverse Events (AEs) | Measured from treatment initiation through Week 96 | Treatment Related Adverse Events were determined by the study sites indicating a relationship between an adverse event and the study treatment. | ClinicalTrials.gov |
| Secondary | Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Measured at Baseline and Weeks 24, 72, and 96 | The normalized composite neurocognitive test score (total z-score) was defined as the average of the z-scores from the following tests: Domestic and International Participants: * Grooved pegboard dominant * Grooved pegboard non-dominant * 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 Making A * Trail Making B * WAIS-III Symbol search * Digit Symbol International only: * Timed Gait * Finger Tapping Dominant * Finger Tapping Non-dominant * Color Trail 1 * Color Trail 2 Z-scores were calculated using a demographically appropriate norming process. Higher z-scores correspond with better neurocognitive performance. Change was calculated as the total z-score at the given time point minus the total z-score at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Functional Status Scores | Measured at Baseline and Weeks 24, 48, 72, and 96 | Functional status scores were calculated based on the instrumental activities of daily living (IADLs) forms. IADL scores were calculated as the sum of the eight IADL tasks where the task scores were equal to 1 if a participant did not need assistance with the task and equal to 0 if a participant needed some level of help with the task. The maximum possible functional status score was 8, while the minimum possible functional status score was 0, with higher functional status scores indicating a higher level of functionality. | ClinicalTrials.gov |
| Secondary | Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL | Measured at Weeks 24, 48, and 96 | The number of participants with Plasma HIV-1 RNA greater than or equal to 50 copies/mL was assessed at each given time point. | ClinicalTrials.gov |
| Secondary | CD4+ T-cell Counts | Measured at Weeks 24, 48, and 96 | CD4+ T-cell counts were recorded at the given time point | ClinicalTrials.gov |
| Secondary | Change in CD4+ T-cell Count | Measured at Baseline and Weeks 24, 48, and 96 | Changes in CD4+ T-cell count were calculated as the CD4+ T-cell count at a given time point minus the CD4+ T-cell count at Baseline. | ClinicalTrials.gov |
| Secondary | CD8+ T-cell Counts | Measured at Weeks 24, 48, and 96 | CD8+ T-cell counts were recorded at the given time point | ClinicalTrials.gov |
| Secondary | Change in CD8+ T-cell Count | Measured at Baseline and Weeks 24, 48, and 96 | Changes in CD8+ T-cell count were calculated as the CD8+ T-cell count at a given time point minus the CD8+ T-cell count at baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 sCD14 in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 sCD14 in Plasma were calculated as the Log10 sCD14 in Plasma at Week 48 minus the Log10 sCD14 in Plasma at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 MIP-1 Beta in Plasma were calculated as the Log10 MIP-1 Beta in Plasma at Week 48 minus the Log10 MIP-1 Beta in Plasma at Baseline. Results below the lower limit of quantification were set to the lower limit value of 11. | ClinicalTrials.gov |
| Secondary | Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 sTNFr-II in Plasma were calculated as the Log10 sTNFr-II in Plasma at Week 48 minus the Log10 sTNFr-II in Plasma at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 VCAM in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 VCAM in Plasma were calculated as the Log10 VCAM in Plasma at Week 48 minus the Log10 VCAM in Plasma at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 MIP-1 Beta in CSF were calculated as the Log10 MIP-1 Beta in CSF at Week 48 minus the Log10 MIP-1 Beta in CSF at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 IP-10 in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 IP-10 in CSF were calculated as the Log10 IP-10 in CSF at Week 48 minus the Log10 IP-10 in CSF at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 Neopterin in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 Neopterin in CSF were calculated as the Log10 Neopterin in CSF at Week 48 minus the Log10 Neopterin in CSF at Baseline. | ClinicalTrials.gov |
| Secondary | Change in Log10 NFL in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | Changes in Log10 NFL in CSF were calculated as the Log10 NFL in CSF at Week 48 minus the Log10 NFL in CSF at Baseline. | ClinicalTrials.gov |
| Other | Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA) | Measured at Baseline and Week 48 | This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing. | ClinicalTrials.gov |
| Other | Changes in T Cell and Monocyte Activation | Measured at Baseline and Week 48 | This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing. | ClinicalTrials.gov |
| Other | Changes in Residual Viremia | Measured at Baseline and Week 48 | This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome due to lack of funding for testing. | ClinicalTrials.gov |
Outcomes 20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline | Measured at Baseline and Week 48 | All participants who started study treatment were included in the analysis. Analysis performed under intention to treat (ITT) principle, all eligible randomized participants were included in the analysis. | total neurocognitive z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Treatment Related Adverse Events (AEs) | Measured from treatment initiation through Week 96 | All participants who were randomized were included in the analysis | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Measured at Baseline and Weeks 24, 72, and 96 | All participants who started study treatment were included in the analysis. Analysis performed under intention to treat (ITT) principle, all eligible randomized participants were included in the analysis. | total neurocognitive z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Functional Status Scores | Measured at Baseline and Weeks 24, 48, 72, and 96 | All participants who started study treatment were included in the analysis. Analysis performed under intention to treat (ITT) principle, all eligible randomized participants were included in the analysis. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Number of Participants With Plasma HIV-1 RNA Greater Than or Equal to 50 Copies/mL | Measured at Weeks 24, 48, and 96 | The analysis included all participants who started study treatment and had Plasma HIV-1 RNA measured at the scheduled study visits. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | CD4+ T-cell Counts | Measured at Weeks 24, 48, and 96 | The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in CD4+ T-cell Count | Measured at Baseline and Weeks 24, 48, and 96 | The analysis included all participants who started study treatment and had CD4+ T-cell counts measured at the scheduled study visits. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | CD8+ T-cell Counts | Measured at Weeks 24, 48, and 96 | The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in CD8+ T-cell Count | Measured at Baseline and Weeks 24, 48, and 96 | The analysis included all participants who started study treatment and had CD8+ T-cell counts measured at the scheduled study visits. | cells/mm^3 | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 sCD14 in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48. | Log10 ng/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 MIP-1 Beta in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 sTNFr-II in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 VCAM in Plasma at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had plasma samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 MIP-1 Beta in Cerebrospinal Fluid (CSF) at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 IP-10 in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 Neopterin in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 | Log10 nmol/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Change in Log10 NFL in CSF at Week 48 From Baseline | Measured at Baseline and Week 48 | The analysis population consisted of all participants who had CSF samples available at Baseline and Week 48 | Log10 pg/mL | MEAN | ClinicalTrials.gov |
| OTHER_PRE_SPECIFIED | Changes in Cell-associated HIV-1 RNA/DNA/2-long Terminal Repeat Sequences (LTR) Circles and Single Copy Assay (SCA) | Measured at Baseline and Week 48 | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Changes in T Cell and Monocyte Activation | Measured at Baseline and Week 48 | ClinicalTrials.gov | |||
| OTHER_PRE_SPECIFIED | Changes in Residual Viremia | Measured at Baseline and Week 48 | ClinicalTrials.gov |
Results by group 96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline | Arm A: Placebo MVC and Placebo DTG | 0.20 | 95% Confidence Interval 0.02 to 0.37 | total neurocognitive z-score | ClinicalTrials.gov | |
| Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline | Arm B: DTG and Placebo MVC | 0.26 | 95% Confidence Interval 0.11 to 0.40 | total neurocognitive z-score | ClinicalTrials.gov | |
| Change in Normalized Composite Neurocognitive Test Score at Week 48 From Baseline | Arm C: MVC and DTG | 0.31 | 95% Confidence Interval 0.16 to 0.46 | total neurocognitive z-score | ClinicalTrials.gov | |
| Number of Participants With Treatment Related Adverse Events (AEs) | Arm A: Placebo MVC and Placebo DTG | 3 | Participants | ClinicalTrials.gov | ||
| Number of Participants With Treatment Related Adverse Events (AEs) | Arm B: DTG and Placebo MVC | 5 | Participants | ClinicalTrials.gov | ||
| Number of Participants With Treatment Related Adverse Events (AEs) | Arm C: MVC and DTG | 7 | Participants | ClinicalTrials.gov | ||
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm A: Placebo MVC and Placebo DTG | Change of Normalized Composite Neurocognitive Test Score (Week 24) | 0.14 | 95% Confidence Interval -0.02 to 0.30 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm B: DTG and Placebo MVC | Change of Normalized Composite Neurocognitive Test Score (Week 24) | 0.18 | 95% Confidence Interval 0.08 to 0.28 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm C: MVC and DTG | Change of Normalized Composite Neurocognitive Test Score (Week 24) | 0.20 | 95% Confidence Interval 0.07 to 0.33 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm A: Placebo MVC and Placebo DTG | Change of Normalized Composite Neurocognitive Test Score (Week 72) | 0.29 | 95% Confidence Interval 0.12 to 0.45 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm B: DTG and Placebo MVC | Change of Normalized Composite Neurocognitive Test Score (Week 72) | 0.32 | 95% Confidence Interval 0.19 to 0.46 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm C: MVC and DTG | Change of Normalized Composite Neurocognitive Test Score (Week 72) | 0.37 | 95% Confidence Interval 0.23 to 0.50 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm A: Placebo MVC and Placebo DTG | Change of Normalized Composite Neurocognitive Test Score (Week 96) | 0.37 | 95% Confidence Interval 0.19 to 0.55 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm B: DTG and Placebo MVC | Change of Normalized Composite Neurocognitive Test Score (Week 96) | 0.34 | 95% Confidence Interval 0.21 to 0.47 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Normalized Composite Neurocognitive Test Score at Weeks 24, 72, and 96 From Baseline | Arm C: MVC and DTG | Change of Normalized Composite Neurocognitive Test Score (Week 96) | 0.38 | 95% Confidence Interval 0.23 to 0.52 | total neurocognitive z-score | ClinicalTrials.gov |
| Change in Functional Status Scores | Arm A: Placebo MVC and Placebo DTG | Change from Baseline in IADL Score (Week 24) | 0.29 | 95% Confidence Interval -0.04 to 0.61 | units on a scale | ClinicalTrials.gov |
| Change in Functional Status Scores | Arm B: DTG and Placebo MVC | Change from Baseline in IADL Score (Week 24) | 0.43 | 95% Confidence Interval 0.07 to 0.80 | units on a scale | ClinicalTrials.gov |
| Change in Functional Status Scores | Arm C: MVC and DTG | Change from Baseline in IADL Score (Week 24) | 0.15 | 95% Confidence Interval -0.19 to 0.49 | units on a scale | ClinicalTrials.gov |
| Change in Functional Status Scores | Arm A: Placebo MVC and Placebo DTG | Change from Baseline in IADL Score (Week 48) | 0.38 | 95% Confidence Interval 0.12 to 0.64 | units on a scale | ClinicalTrials.gov |
| Change in Functional Status Scores | Arm B: DTG and Placebo MVC | Change from Baseline in IADL Score (Week 48) | 0.45 | 95% Confidence Interval 0.11 to 0.79 | units on a scale | ClinicalTrials.gov |
Participant flow 9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Placebo MVC and Placebo DTG | 63 | ClinicalTrials.gov | |
| Overall Study | STARTED | Arm B: DTG and Placebo MVC | 67 | ClinicalTrials.gov | |
| Overall Study | STARTED | Arm C: MVC and DTG | 61 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Arm A: Placebo MVC and Placebo DTG | 57 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Arm B: DTG and Placebo MVC | 59 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Arm C: MVC and DTG | 57 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Arm A: Placebo MVC and Placebo DTG | 6 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Arm B: DTG and Placebo MVC | 8 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Arm C: MVC and DTG | 4 | ClinicalTrials.gov |
Adverse events 162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Arm A (Placebo DTG/Placebo MVC) | 2 | 63 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | Arm B (DTG/Placebo MVC) | 3 | 67 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | Arm C (DTG/MVC) | 3 | 60 | ClinicalTrials.gov | |
| other | Chest pain | General disorders | Arm A (Placebo DTG/Placebo MVC) | 0 | 63 | ClinicalTrials.gov | |
| other | Chest pain | General disorders | Arm B (DTG/Placebo MVC) | 0 | 67 | ClinicalTrials.gov | |
| other | Chest pain | General disorders | Arm C (DTG/MVC) | 4 | 60 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | Arm A (Placebo DTG/Placebo MVC) | 2 | 63 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | Arm B (DTG/Placebo MVC) | 4 | 67 | ClinicalTrials.gov | |
| other | Fatigue | General disorders | Arm C (DTG/MVC) | 2 | 60 | ClinicalTrials.gov | |
| other | Pain | General disorders | Arm A (Placebo DTG/Placebo MVC) | 0 | 63 | ClinicalTrials.gov | |
| other | Pain | General disorders | Arm B (DTG/Placebo MVC) | 1 | 67 | ClinicalTrials.gov | |
| other | Pain | General disorders | Arm C (DTG/MVC) | 3 | 60 | ClinicalTrials.gov | |
| other | Pyrexia | General disorders | Arm A (Placebo DTG/Placebo MVC) | 3 | 63 | ClinicalTrials.gov | |
| other | Pyrexia | General disorders | Arm B (DTG/Placebo MVC) | 4 | 67 | ClinicalTrials.gov | |
| other | Pyrexia | General disorders | Arm C (DTG/MVC) | 3 | 60 | ClinicalTrials.gov | |
| other | Influenza | Infections and infestations | Arm A (Placebo DTG/Placebo MVC) | 1 | 63 | ClinicalTrials.gov | |
| other | Influenza | Infections and infestations | Arm B (DTG/Placebo MVC) | 2 | 67 | ClinicalTrials.gov | |
| other | Influenza | Infections and infestations | Arm C (DTG/MVC) | 3 | 60 | ClinicalTrials.gov | |
| other | Alanine aminotransferase increased | Investigations | Arm A (Placebo DTG/Placebo MVC) | 4 | 63 | ClinicalTrials.gov | |
| other | Alanine aminotransferase increased | Investigations | Arm B (DTG/Placebo MVC) | 3 | 67 | ClinicalTrials.gov |
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Arm A (Placebo DTG/Placebo MVC) | 1 | 63 | ClinicalTrials.gov |
| Total, all-cause mortality | Arm B (DTG/Placebo MVC) | 0 | 67 | ClinicalTrials.gov |
| Total, all-cause mortality | Arm C (DTG/MVC) | 0 | 60 | ClinicalTrials.gov |
| Total, other adverse events | Arm A (Placebo DTG/Placebo MVC) | 31 | 63 | ClinicalTrials.gov |
| Total, other adverse events | Arm B (DTG/Placebo MVC) | 32 | 67 | ClinicalTrials.gov |
| Total, other adverse events | Arm C (DTG/MVC) | 37 | 60 | ClinicalTrials.gov |
| Total, serious adverse events | Arm A (Placebo DTG/Placebo MVC) | 6 | 63 | ClinicalTrials.gov |
| Total, serious adverse events | Arm B (DTG/Placebo MVC) | 12 | 67 | ClinicalTrials.gov |
| Total, serious adverse events | Arm C (DTG/MVC) | 9 | 60 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Scan Task | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)