Trial · NCT02842086
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of HIV-1 Infection Per 100 Person Years (PY) | When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks) | The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, were not HIV positive on Day 1, and had at least 1 postbaseline HIV laboratory assessment. | HIV-1 infections per 100 PY | NUMBER |
| SECONDARY | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Baseline, Week 48 | Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing hip BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Baseline, Week 48 | Spine DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing spine BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Incidence of HIV-1 Infection Per 100 PY | When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks) | Participants in Full Analysis Set were analyzed. | HIV-1 infections per 100 PY | NUMBER |
| SECONDARY | Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Hip DXA Analysis Set with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Spine DXA Analysis Set with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Safety Analysis Set with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Safety Analysis Set with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Safety Analysis Set with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Safety Analysis Set with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) | Participants in Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks) | Participants in Safety Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
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