Trial · NCT03041012
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma HIV RNA kinetics | 3 months | Time to undetectable (\<20 c/mL) |
| Primary | Quantification of the size of the proviral HIV reservoir | 1 year | Copies of total HIV-1 DNA per 10⁶ CD4+ T cells as measured by digital droplet PCR |
| Primary | Time to viral rebound during ATI | 12 weeks | Days from stopping ART to plasma HIV RNA \>5,000 on two consecutive measurements |
| Secondary | Incidence of treatment emerging events (Safety and tolerability) | 1 year | Frequence and severity of adverse events (AE), adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and suspected unexpected serious adverse reactions (SUSAR). |
| Secondary | Quantification of the intact proviral DNA | 1 year | Intact HIV-1 DNA in CD4+ T cells (copies per million cells) as measured by dd-PCR. |
| Secondary | Quantification of HIV mRNA and/or p24 positive cells | 30 days from study entry | Frequency of mRNA/p24 postive per 1 million CD4+ T cells by FISH-flow |
| Secondary | Immune reconstitution | 1 year | Absolute CD4+ and CD8+ T cell count |
| Secondary | Analytic treatment interruption (ATI) study | 64 weeks | Time to first plasma HIV RNA \>5000 c/mL |
| Secondary | Impact of pre-ART virus sensitivity to 3BNC117 on ATI outcomes | Baseline and at viral rebound | 3BNC117 sensitivity determined by PhenoSense and/or HIV env sequencing |
| Secondary | T cell mediated HIV specific immunity | First of 365 days | T cell immunity as determined by the HIV AIM assay |
| Other | Plasma cytokine and immune activation biomarker levels | 1 year | Soluble IL-6, sCD14, sCD163 |
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/NCT03041012/registered