Trial · NCT02275780
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels \<50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. |
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels \<50 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. |
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 48 | Baseline and Week 48 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. |
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 96 | Baseline and Week 96 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. |
| Secondary | Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Baseline and Week 48 | Serum LDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid-lowering therapy. |
| Secondary | Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Baseline and Week 48 | Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. |
| Secondary | Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48 | Baseline and Week 48 | Serum HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. |
| Secondary | Mean Change From Baseline in Fasting Total Cholesterol at Week 48 | Baseline and Week 48 | Serum total cholesterol was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. |
| Secondary | Mean Change From Baseline in Fasting Triglyceride at Week 48 | Baseline and Week 48 | Serum triglyceride was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. |
| Secondary | Percentage of Participants With Any Adverse Event | Up to 98 weeks | An adverse event (AE) is defined as any untoward medical occurrence in a study participant and which does not necessarily have to have a causal relationship to treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study treatment is also an AE. The percentage of participants with any AE was assessed. |
| Secondary | Percentage of Participants With Any Serious Adverse Event | Up to 98 weeks | A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. |
| Secondary | Percentage of Participants With Any Drug-related Adverse Event | Up to 98 weeks | The investigator was to determine if an AE had a reasonable possibility of a relationship to the study drug. The percentage of participants with any drug-related AE was assessed. |
| Secondary | Percentage of Participants With Any Drug-related Serious Adverse Event | Up to 98 weeks | The percentage of participants with any drug-related SAE was assessed. |
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event | Up to 96 weeks | The percentage of participants who discontinued study treatment due to an AE was assessed. |
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 48 | Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels \<40 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. |
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 96 | Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels \<40 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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