Trial · NCT02842086
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 | 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 incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results) |
| Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| Secondary | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| 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 | The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP \< 4.0 mg/dL and participants with UPCR ≤ 200 mg/g. |
| Secondary | Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase | Baseline, Week 48 | |
| 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) | The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results) |
| Secondary | Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| Secondary | Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| Secondary | Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase | Baseline, Week 96 | The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP \< 4.0 mg/dL and participants with UPCR ≤ 200 mg/g. |
| Secondary | Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase | Baseline, Week 96 | |
| 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) | |
| 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) |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02842086/registered