Trial Outcomes & Findings for A Single Dose of Pembrolizumab in HIV-Infected People (NCT NCT03367754)
NCT ID: NCT03367754
Last Updated: 2025-01-17
Results Overview
Participants with either grade 2 or higher autoimmune events requiring corticosteroid therapy or grade 3 or higher adverse events that are possibly, probably, or definitely related to intervention. The severity of each adverse event was graded according to the "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events". Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for ≤ 24 hrs. Grade 3: Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to 48 weeks from start of intervention
Results posted on
2025-01-17
Participant Flow
11 participants were enrolled on the study. Three participants were screen failure and one participants withdrew prior to start of study.
Participant milestones
| Measure |
Drug: Pembrolizumab
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion.
|
Placebo
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Placebo via intravenous (IV) infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Dose of Pembrolizumab in HIV-Infected People
Baseline characteristics by cohort
| Measure |
Drug: Pembrolizumab
n=6 Participants
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion.
|
Placebo
n=1 Participants
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Placebo via intravenous (IV) infusion.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeks from start of interventionPopulation: Analysis included all participants who received study intervention.
Participants with either grade 2 or higher autoimmune events requiring corticosteroid therapy or grade 3 or higher adverse events that are possibly, probably, or definitely related to intervention. The severity of each adverse event was graded according to the "Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events". Grade 2: Therapy or infusion interruption indicated but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDS, narcotics, IV fluids); prophylactic medications indicated for ≤ 24 hrs. Grade 3: Prolonged (eg, not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death
Outcome measures
| Measure |
Drug: Pembrolizumab
n=6 Participants
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion.
|
Placebo
n=1 Participants
Participants with HIV and CD4+ of 100-350 cells/mm\^3 receive a single dose of Placebo via intravenous (IV) infusion.
|
|---|---|---|
|
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
Grade 2 or higher autoimmune events requiring corticosteroid therapy
|
0 Participants
|
0 Participants
|
|
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
Grade 5
|
0 Participants
|
0 Participants
|
Adverse Events
Drug: Pembrolizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug: Pembrolizumab
n=6 participants at risk
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion.
|
Placebo
n=1 participants at risk
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Placebo via intravenous (IV) infusion.
|
|---|---|---|
|
General disorders
Chest pain
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
Other adverse events
| Measure |
Drug: Pembrolizumab
n=6 participants at risk
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion.
|
Placebo
n=1 participants at risk
Participants with HIV and CD4+ of 100-350 cells/mm\^3 received a single dose of Placebo via intravenous (IV) infusion.
|
|---|---|---|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Eye disorders
Vitreous floaters
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
General disorders
Cyst
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
General disorders
Fatigue
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
General disorders
Pain
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Immune system disorders
Seasonal allergy
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Fungal infection
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Furuncle
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Gonorrhoea
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Herpes simplex
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Herpes zoster
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Cardiac disorders
Coronary artery disease
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Ear and labyrinth disorders
Motion sickness
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Endocrine disorders
Thyroid mass
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Sinusitis
|
50.0%
3/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Injury, poisoning and procedural complications
Animal bite
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood cholesterol increased
|
83.3%
5/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood corticotrophin abnormal
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood glucose increased
|
50.0%
3/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood phosphorus decreased
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood sodium increased
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood thyroid stimulating hormone increased
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Blood triglycerides increased
|
83.3%
5/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Investigations
Low density lipoprotein increased
|
66.7%
4/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Nervous system disorders
Carpal tunnel syndrome
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Psychiatric disorders
Depression
|
33.3%
2/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Up to 96 weeks from administration of intervention
|
100.0%
1/1 • Up to 96 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Surgical and medical procedures
Tooth extraction
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Up to 96 weeks from administration of intervention
|
0.00%
0/1 • Up to 96 weeks from administration of intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place