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PD-1 Inhibitor

Pembrolizumab for HIV/AIDS

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
Must not have
Females who are pregnant or breastfeeding
Active or history of tuberculosis (TB), or positive TB QuantiFERON Gold test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks after receiving the study drug.

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.
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.
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
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I am 18 years old or older.
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My HIV is under control with a viral load under 40 copies/mL for the past year.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min/1.73 m2 or higher.
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I have been diagnosed with HIV-1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have or had tuberculosis, or my TB test is positive.
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I do not have any severe or unstable heart, lung, liver diseases, other cancers, serious illnesses, or infections needing treatment.
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I am on maintenance therapy for an opportunistic infection.
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I have or had lung inflammation not caused by an infection.
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I need or have needed cancer treatment in the last 5 years.
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I have active hepatitis C.
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I have been diagnosed with osteoporosis or diabetes.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I have active hepatitis B or a risk of its reactivation.
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I have used an immunotherapy treatment within the last 6 months.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 2 or higher autoimmune events requiring corticosteroid therapy.
The occurrence of Grade 3 or higher AEs.

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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 3
~3150

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,879,831 Total Patients Enrolled
Joseph A Kovacs, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
11 Previous Clinical Trials
3,692 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03367754 — Phase 1
HIV/AIDS Research Study Groups: 1, 2
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
~4 spots leftby May 2025
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