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Pembrolizumab for Human Immunodeficiency Virus Infection

Phase 1

Waitlist Available

Led By Avindra Nath, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study duration (up to 52 weeks post infusion)

Awards & highlights

Study Summary

This trial is for people with HIV to see if the cancer drug pembrolizumab is safe, not to treat HIV.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study duration (up to 52 weeks post infusion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study duration (up to 52 weeks post infusion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study duration (up to 52 weeks post infusion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of Grade 3 or Higher Adverse Events

Secondary outcome measures

Change in CSF Cytokine Profile Post-study Drug

Change in FDG-PET/CT Metabolic Uptake in CNS

Change in HIV-specific Antibody Responses in the CSF and Serum Using LIPS Assay.

+3 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: HIV ParticipantsExperimental Treatment1 Intervention

Participants who received 200 mg of Pembrolizumab administered as a one-time intravenous infusion over 30 minutes during the treatment phase of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,340 Previous Clinical Trials

649,351 Total Patients Enrolled

Avindra Nath, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

10 Previous Clinical Trials

5,507 Total Patients Enrolled

Lauren B Reoma, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

2 Previous Clinical Trials

1,312 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what ailments has Pembrolizumab been demonstrated to be effective?

"Pembrolizumab is often used to treat cancerous tumours. It can also be employed in the treatment of unresectable melanoma, microsatellite instability high, and as a response to chemotherapy failure."

Answered by AI

What is the greatest number of people taking part in this experiment?

"Affirmative. Clinicaltrials.gov documents that this medical trial, launched on April 9th 2018, is actively recruiting patients. Currently they are searching for 20 participants from 1 research center to take part in the study."

Answered by AI

Are individuals still able to join this research investigation?

"Verified. Clinicaltrials.gov details that this medical trial, created on April 9th 2018, is actively recruiting participants. Twenty individuals will need to be sourced from one location for the research project to commence."

Answered by AI

What adverse effects have been associated with Pembrolizumab treatment?

"Due to a lack of clinical data, the safety rating for Pembrolizumab was assigned a score of 1. This is because this drug is currently in its initial testing phase and has yet to be fully evaluated."

Answered by AI

How has Pembrolizumab fared in prior studies?

"Presently, there are 961 trials researching the efficacy of pembrolizumab. Of these existing studies, 122 have advanced to Phase 3 clinical trial testing. These tests can be found across 35 731 locations worldwide; however Houston, Texas is a major hub for research regarding this drug."

Answered by AI

Recent research and studies

Journal of VirologyJournal

Advances Toward Curing HIV-1 Infection in Tissue Reservoirs

Henderson, Lisa J., Lauren B. Reoma, Joseph A. Kovacs, and Avindra Nath. 2020. “Advances Toward Curing HIV-1 Infection in Tissue Reservoirs”. Edited by Ted C. Pierson. Journal of Virology. American Society for Microbiology. doi:10.1128/jvi.00375-19.

clinicaltrials.govStudy

PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection

2018. "PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03239899.