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PD-1 Inhibitor

Pembrolizumab for HIV/AIDS

Q: Have the FDA sanctioned Pembrolizumab for medicinal purposes?

As the safety of Pembrolizumab has only been studied in a limited capacity, our team at Power have assigned it an initial rating of 1.

Q: Are there any vacancies open to participants in this clinical trial?

According to the information on clinicaltrials.gov, this medical trial is currently enrolling participants with its first posting taking place in August 6th 2018 and last update occuring September 1st 2022.

Q: Does this experiment accept individuals aged 65 and above?

This study is open to adults aged 18-99 years old.

Q: How many participants are included in this clinical study?

Affirmative, clinicaltrials.gov attests that this medical trial is presently recruiting participants. This research program was initially posted on August 6th 2018 and updated most recently on September 1st 2022; currently looking to enrol 60 patients at one location.

Q: Is eligibility open to join this investigation?

This research study is currently recruiting 60 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive individuals aged 18 to 99. Submissions are accepted from candidates who meet certain prerequisites, including documented HIV infection (through ELISA or rapid antibody tests), neutrophil count greater than 1000/microliter, platelet count over 125,000/microlitre., haemoglobin levels of 10g/dL and above, calculated glomerular filtration rate of at least 60mL per minute per 1.73 metres squared., normal TSH and ACTH readings [or thyroxine if the former isn't within range], no severe pulmonary issues as well as cardiac, renal

Q: Are there any precedent clinical trials regarding Pembrolizumab?

At present, nearly a thousand trials are underway concerning pembrolizumab. Out of those active studies, 122 have reached the third stage of testing and development. This medication is primarily being tested in Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> although there are over 35000 other locations that also run these tests.

Q: In what therapeutic context is Pembrolizumab commonly prescribed?

Pembrolizumab is an effective treatment for malignant neoplasms, unresectable melanomas, and cases of microsatellite instability high.

Phase 1

Recruiting

Led By Joseph A Kovacs, M.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

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

Must have

Individuals must be greater than or equal to 18 years of age

Must have HIV suppression with viral load < 40 copies/mL for at least 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 weeks after receiving the study drug.

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe to use in people with HIV who have a low CD4+ T cell count, and to see if it strengthens the immune system.

Who is the study for?

Adults over 18 with HIV, on antiretroviral drugs, undetectable blood HIV levels, and low CD4+ T-cell count (below 350 cells/mm3). Must have certain blood cell counts within normal ranges, no severe organ disease, not pregnant or breastfeeding, agree to birth control use and genetic testing. Cannot have used steroids/immunosuppressants recently or have active hepatitis/tuberculosis.Check my eligibility

What is being tested?

The trial is testing pembrolizumab's safety in people with HIV who still have a low CD4+ T-cell count despite treatment. Participants will receive either the drug or a placebo via IV and be monitored for up to 96 weeks through visits and phone calls.See study design

What are the potential side effects?

While specific side effects are not listed here, pembrolizumab can generally cause immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, skin rashes among others. Close monitoring during the trial aims to identify any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My HIV is under control with a viral load under 40 copies/mL for the past year.

Select...

My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min/1.73 m2 or higher.

Select...

I have been diagnosed with HIV-1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks after receiving the study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks after receiving the study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks after receiving the study drug for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Grade 2 or higher autoimmune events requiring corticosteroid therapy.

The occurrence of Grade 3 or higher AEs.

Secondary outcome measures

Magnitude and duration of decreased expression of PD-1 relative to baseline levels on lymphocytes

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1Experimental Treatment1 Intervention

single dose of 200 mg (IV) infusion

Group II: 2Placebo Group1 Intervention

single dose (IV infusion)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

880,942 Total Patients Enrolled

Joseph A Kovacs, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

11 Previous Clinical Trials

3,757 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03367754 — Phase 1

HIV/AIDS Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03367754 — Phase 1

Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03367754 — Phase 1

Frequently Asked Questions

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

Have the FDA sanctioned Pembrolizumab for medicinal purposes?

"As the safety of Pembrolizumab has only been studied in a limited capacity, our team at Power have assigned it an initial rating of 1."

Answered by AI

Are there any vacancies open to participants in this clinical trial?

"According to the information on clinicaltrials.gov, this medical trial is currently enrolling participants with its first posting taking place in August 6th 2018 and last update occuring September 1st 2022."

Answered by AI

Does this experiment accept individuals aged 65 and above?

"This study is open to adults aged 18-99 years old."

Answered by AI

How many participants are included in this clinical study?

"Affirmative, clinicaltrials.gov attests that this medical trial is presently recruiting participants. This research program was initially posted on August 6th 2018 and updated most recently on September 1st 2022; currently looking to enrol 60 patients at one location."

Answered by AI

Is eligibility open to join this investigation?

"This research study is currently recruiting 60 HIV-positive individuals aged 18 to 99. Submissions are accepted from candidates who meet certain prerequisites, including documented HIV infection (through ELISA or rapid antibody tests), neutrophil count greater than 1000/microliter, platelet count over 125,000/microlitre., haemoglobin levels of 10g/dL and above, calculated glomerular filtration rate of at least 60mL per minute per 1.73 metres squared., normal TSH and ACTH readings [or thyroxine if the former isn't within range], no severe pulmonary issues as well as cardiac, renal"

Answered by AI

Are there any precedent clinical trials regarding Pembrolizumab?

"At present, nearly a thousand trials are underway concerning pembrolizumab. Out of those active studies, 122 have reached the third stage of testing and development. This medication is primarily being tested in Houston, Texas although there are over 35000 other locations that also run these tests."

Answered by AI