Trial · NCT02408861
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Nivolumab | Each patient will be evaluated for DLT for the safety evaluation period of 6 weeks | Safety evaluable population treated with at least a single dose of Nivolumab. | mg/kg | NUMBER |
| PRIMARY | Dose Limiting Toxicities (DLTs) Observed in Dose De-escalation Cohorts | 6 weeks from the first dose of Nivolumab | Patients evaluated for safety during 6 weeks from the first dose | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Adverse Events According to NCI CTCAE v5.0 | Participants will be followed for 16 weeks or 112 days after removal from study treatment, or until death, whichever occurs first. | Events | NUMBER | |
| SECONDARY | Objective Response Rate | Up to 3 years | Patients exposed to at least a single dose of study drug(s) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | Immune Function, Defined as CD4 and CD8 Cell Counts at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+ 16 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 6 Weeks | end of 46 cycles of treatment+ 6 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 6 weeks visit | cells/mm3 | MEDIAN |
| SECONDARY | HIV Viral Load at Baseline and at End of 46 Cycles of Treatment+ 16 Weeks | end of 46 cycles of treatment+16 weeks | Enrolled participants who have data available for both baseline and end of 46 cycles of treatment+ 16 weeks visit | cells/mm3 | MEDIAN |
| OTHER_PRE_SPECIFIED | Intratumor Immune Cells | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Circulating Cytokine Markers | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Herpesvirus Loads (Epstein-Barr Virus [EBV], Kaposi Sarcoma Herpes Virus [KSHV], Cytomegalovirus [CMV]) in Plasma | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Latent Herpesvirus (EBV, KSHV, CMV) in Peripheral Blood Mononuclear Cell (PBMC) | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Herpesvirus Specific CD8 and CD4 T Cells in PBMC | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Viral Transcription in Tumor Biopsies (Kaposi Sarcoma Cases) | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Human Papillomavirus Types in Anal Swabs (Anal Cancer Cases) | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Latent HIV Loads in PBMC | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | HIV Reactive T Cells | Up to 3 years |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02408861/outcomes