Human Immunodeficiency VirusPhase 1NCT03367754
A Single Dose of Pembrolizumab in HIV-Infected People
A Phase 1 study testing Pembrolizumab in people with Human Immunodeficiency Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low CD4+ T-cell count despite taking antiviral medicines that control HIV replication. These cells fight disease, so a low count makes it easier for people to become sick. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 18 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following criteria to be eligible for study participation:
- Greater than or equal to 18 years of age.
- Documented HIV-1 infection (eg, positive standard enzyme-linked immunosorbent assay or rapid HIV-1/HIV-2 antibody test with a confirmatory test such as western blot, or documentation of repeated HIV RNA of > 1000 copies/mL). Outside documentation will be acceptable.
- Absolute neutrophil count > 1000/microliter.
- Platelet count > 125,000/microliter.
- Hemoglobin > 10 g/dL.
Show all 19Show fewer
- Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.1 times the upper limit of normal (ULN). Total bilirubin < 1.1 x ULN (unless participant is taking atazanavir or has Gilbert syndrome).
- Calculated creatinine clearance (estimated glomerular filtration rate) greater than or equal to 60 mL/min/1.73 m2.
- Thyroid-stimulating hormone (TSH) and adrenocorticotropic hormone (ACTH) within normal limits. If TSH is not within normal limits then the participant may be eligible if thyroxine (T4) is within normal limits. Participants will not be excluded if they are on a stable dose of replacement thyroid medication; dose may be adjusted as needed.
- No significant underlying pulmonary, cardiac, renal, or hepatic disease, as defined by a need for drug treatment or ongoing physician care.
- Under the care of a primary care physician.
- Willing to comply with study requirements and procedures including storage of biological specimens for future use in medical research.
- Willing to allow genetic testing.
- Able to provide informed consent.
- Participants of reproductive potential must agree to not become pregnant or to impregnate a partner beginning 30 days before the dose of pembrolizumab through 120 days post dose.
- Participants must meet criteria for INR, defined as follows:
- Has been on a cART regimen for at least 12 months and on a stable regimen for at least 4 weeks.
- Has HIV suppression, defined as viral load < 40 copies/mL, and documented suppression (below detection limits of the utilized assay) for at least 12 months. A viral load of < 500 copies/mL once in the year preceding screening will be allowed if there is documentation of a viral load < 40 copies/mL on subsequent testing and at screening.
- CD4+ T-cell count > 100 cells/mm3 and less than or equal to 350 cells/mm3.
Who cannot join
- Females who are pregnant or breastfeeding.
- Has used an investigational drug agent or investigational device within 12 weeks of baseline.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Known allergy to any component of the pembrolizumab formulation.
- Systemic steroid therapy or other immunosuppressive therapy in the 3 months prior to enrollment (Inhaled or topical corticosteroids are permitted).
- Has used an immunotherapeutic agent within 6 months of baseline.
Show all 24Show fewer
- Plans to receive any vaccine within 16 weeks of receiving pembrolizumab.
- Has active autoimmune disease or a history of autoimmune disease that has required systemic treatment (eg, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, T4) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Malignancy requiring systemic therapy, or a history of malignancy that required systemic therapy within the past 5 years. However, cutaneous basal cell carcinoma or cutaneous Kaposi sarcoma not requiring systemic therapy will not be exclusionary.
- Has known active hepatitis B (HBV) or potential for HBV reactivation (eg, hepatitis B surface antigen [HBS] reactive, HBV DNA positive, or isolated anti-core antibody positive; individuals who are anti-HBS antibody positive with or without anti-core Ab are eligible).
- Has known active hepatitis C (HCV; eg, HCV RNA [qualitative] is detected). Patients who have sustained virologic response (SVR) to anti-HCV treatment are eligible if at least 24 weeks have passed since achieving SVR.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- History or other clinical evidence of:
- Significant or unstable cardiac disease
- Significant pulmonary disease
- Severe illness, chronic liver disease, malignancy, immunodeficiency other than HIV, active systemic infection (other than HIV) requiring therapy.
- Opportunistic infection requiring maintenance therapy, including toxoplasmosis, fungal infections other than candida (eg, cryptococcosis, histoplasmosis, coccidioidomycosis), atypical mycobacterial infection. Secondary Pneumocystis, candida, and HSV prophylaxis will be permitted.
- Active or history of tuberculosis (TB), or positive TB QuantiFERON Gold test.
- Known osteoporosis or diabetes mellitus.
- Hemoglobin A1c > 6%.
- Fasting triglyceride > 300 mg/dL.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
- Co-enrollment in other trials is restricted, other than enrollment on observational studies or expanded access studies for antiretroviral agents, during the first 48 weeks of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of a Single Dose of Pembrolizumab in HIV-Infected Patients
Background:
Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low CD4+ T-cell count despite taking antiviral medicines that control HIV replication. These cells fight disease, so a low count makes it easier for people to become sick. Researchers want to see if a new drug can improve the immune system, including T cells. The drug is called pembrolizumab
Read more
Objective:
To see if pembrolizumab is safe to use in people with HIV who have a low CD4+ T cell count despite taking medicines that control HIV replication, and to see if it strengthens the immune system.
Eligibility:
People age 18 years or older with HIV who are taking antiretroviral drugs as treatment, have blood HIV levels below detection limits of commercial assays, and have a low CD4+ T-cell count (below 350 cells/mm3).
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Heart, blood, and urine tests
Sexually active participants must use 2 kinds of birth control.
Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Participants will have a baseline visit. They will have blood tests. They may have a pregnancy test.
A needle will insert a thin plastic tube (IV) into an arm vein. The participants will get the study drug or a placebo through the IV for 30 minutes. They will be watched for a couple hours after.
Participants will have 11 follow-up visits over the next 48 weeks. They will have a physical exam, vital signs, medical review, and blood tests.
Participants may have another leukapheresis.
Participants will be called every 12 weeks after their last follow-up visit to talk about how they feel and their health. Participation ends after the week 96 phone call.
Read the detailed description
A subset of HIV-infected patients, those with poor immunologic response to combined antiretroviral therapy (CD4+ T-cell count of less than 300-350 cells/mm^3) despite control of viremia, are at increased risk for both HIV-related and non-HIV-related complications compared to immunologic responders. Thus, novel approaches for treating HIV infection are needed to facilitate management of this patient population.
One potential drug target for HIV treatment is the T-cell receptor PD-1. Binding of PD-1 to its ligands, PD-L1 and PD-L2, inhibits proliferation of T cells and production of cytokines. This naturally serves to dampen potentially harmful excessive immune responses. Upregulation of PD-1 and/or its ligands can be observed in tumors and people with chronic viral infection, including HIV. This upregulation can inhibit T-cell immune surveillance, which may result in tumor growth or poor control of infection.
Pembrolizumab is an IgG4 kappa monoclonal antibody that binds to PD-1, thus blocking the receptor from binding with its ligands. In cancer indications, inhibition of PD-1 induces an antitumor immune response, which in turn reduces tumor growth. The Food and Drug Administration has approved pembrolizumab for treatment of unresectable or metastatic melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and other cancers. Similarly, in animal models of HIV and in vitro studies, PD-1 blockade was associated with a decrease in viral load and an increase in CD8+ T cells. A clinical trial to examine the effects of PD-1 inhibition by pembrolizumab on HIV infection is thus supported by the data.
The purpose of this study is to evaluate, in a randomized, double-blind, placebo-controlled study, the safety and tolerability of a single dose of pembrolizumab in HIV-infected participants who have controlled viremia with a low T-cell count (> 100 cells/mm3 and less than or equal to 350 cells/mm^3). Study participants will be followed for 96 weeks after receiving the study drug and will be assessed for adverse events, CD4+ and CD8+ T-cell counts, PD-1 expression, CD8+ T-cell anti-HIV activity, and viral load. If a single dose of pembrolizumab appears to be safe and tolerable, then larger multi-dose and efficacy studies can be planned.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Placebo, Pembrolizumab
- Keywords
- Immunotherapy, Immunologic Non-Responder, Immunologic Response, Randomized, PD-1
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Single dose of Placebo given via intravenous (IV) infusion.
PembrolizumabDrug
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (immunoglobulin [Ig] G4 kappa isotype) that binds to PD-1, thus blocking the receptor from binding with its ligands. Single dose of Pembrolizumab 200 mg given via intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Pembrolizumab | Experimental | Participants with HIV and CD4+ of 100-350 cells/mm^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion. Receives: Drug: Pembrolizumab |
| Placebo | Placebo comparator | Participants with HIV and CD4+ of 100-350 cells/mm^3 received a single dose of Placebo via intravenous (IV) infusion. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
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
Measured: Up to 48 weeks from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start6 Aug 2018
- Primary completion17 Dec 2021
- Study completion18 Nov 2024
Why it stopped: Difficulty with subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367754
- Sponsor's protocol ID
- 180013
- Other IDs
- 18-CC-0013
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2017
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Human data generated in this study will be shared for future research as follows: Identified data in the Biomedical Translational Research Information System (BTRIS; automatic for activities in the CC). De-identified or identified data with approved outside collaborators under appropriate agreements. Through publication and/or public presentations. Data sharing may be complicated or limited in certain cases by contractual obligations or agreements with outside collaborators, such as a cooperative research and development agreements, clinical trial agreements, other restraints, etc.
Publications
Gay CL, Bosch RJ, Ritz J, Hataye JM, Aga E, Tressler RL, Mason SW, Hwang CK, Grasela DM, Ray N, Cyktor JC, Coffin JM, Acosta EP, Koup RA, Mellors JW, Eron JJ; AIDS Clinical Trials 5326 Study Team. Clinical Trial of the Anti-PD-L1 Antibody BMS-936559 in HIV-1 Infected Participants on Suppressive Antiretroviral Therapy. J Infect Dis. 2017 Jun 1;215(11):1725-1733. doi: 10.1093/infdis/jix191.
PubMed 28431010Day CL, Kaufmann DE, Kiepiela P, Brown JA, Moodley ES, Reddy S, Mackey EW, Miller JD, Leslie AJ, DePierres C, Mncube Z, Duraiswamy J, Zhu B, Eichbaum Q, Altfeld M, Wherry EJ, Coovadia HM, Goulder PJ, Klenerman P, Ahmed R, Freeman GJ, Walker BD. PD-1 expression on HIV-specific T cells is associated with T-cell exhaustion and disease progression. Nature. 2006 Sep 21;443(7109):350-4. doi: 10.1038/nature05115. Epub 2006 Aug 20.
PubMed 16921384Henderson LJ, Reoma LB, Kovacs JA, Nath A. Advances toward Curing HIV-1 Infection in Tissue Reservoirs. J Virol. 2020 Jan 17;94(3):e00375-19. doi: 10.1128/JVI.00375-19. Print 2020 Jan 17.
PubMed 31694954
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of a Single Dose of Pembrolizumab in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT03367754
- Acronym / sponsor ID
- 180013
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Immunotherapy, Immunologic Non-Responder, Immunologic Response, Randomized, PD-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with subject recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Human immunodeficiency virus (HIV) attacks the immune system. Some people with HIV have a low CD4+ T-cell count despite taking antiviral medicines that control HIV replication. These cells fight disease, so a low count makes it easier for people to become sick. Researchers want to see if a new drug can improve the immune system, including T cells. The drug is called pembrolizumab
Objective:
To see if pembrolizumab is safe to use in people with HIV who have a low CD4+ T cell count despite taking medicines that control HIV replication, and to see if it strengthens the immune system.
Eligibility:
People age 18 years or older with HIV who are taking antiretroviral drugs as treatment, have blood HIV levels below detection limits of commercial assays, and have a low CD4+ T-cell count (below 350 cells/mm3).
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Heart, blood, and urine tests
Sexually active participants must use 2 kinds of birth control.
Participants will have leukapheresis. Blood will be removed through a needle in one arm. A machine will remove white blood cells. The rest of the blood will be returned into the other arm.
Participants will have a baseline visit. They will have blood tests. They may have a pregnancy test.
A needle will insert a thin plastic tube (IV) into an arm vein. The participants will get the study drug or a placebo through the IV for 30 minutes. They will be watched for a couple hours after.
Participants will have 11 follow-up visits over the next 48 weeks. They will have a physical exam, vital signs, medical review, and blood tests.
Participants may have another leukapheresis.
Participants will be called every 12 weeks after their last follow-up visit to talk about how they feel and their health. Participation ends after the week 96 phone call.
Detailed description
A subset of HIV-infected patients, those with poor immunologic response to combined antiretroviral therapy (CD4+ T-cell count of less than 300-350 cells/mm^3) despite control of viremia, are at increased risk for both HIV-related and non-HIV-related complications compared to immunologic responders. Thus, novel approaches for treating HIV infection are needed to facilitate management of this patient population.
One potential drug target for HIV treatment is the T-cell receptor PD-1. Binding of PD-1 to its ligands, PD-L1 and PD-L2, inhibits proliferation of T cells and production of cytokines. This naturally serves to dampen potentially harmful excessive immune responses. Upregulation of PD-1 and/or its ligands can be observed in tumors and people with chronic viral infection, including HIV. This upregulation can inhibit T-cell immune surveillance, which may result in tumor growth or poor control of infection.
Pembrolizumab is an IgG4 kappa monoclonal antibody that binds to PD-1, thus blocking the receptor from binding with its ligands. In cancer indications, inhibition of PD-1 induces an antitumor immune response, which in turn reduces tumor growth. The Food and Drug Administration has approved pembrolizumab for treatment of unresectable or metastatic melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and other cancers. Similarly, in animal models of HIV and in vitro studies, PD-1 blockade was associated with a decrease in viral load and an increase in CD8+ T cells. A clinical trial to examine the effects of PD-1 inhibition by pembrolizumab on HIV infection is thus supported by the data.
The purpose of this study is to evaluate, in a randomized, double-blind, placebo-controlled study, the safety and tolerability of a single dose of pembrolizumab in HIV-infected participants who have controlled viremia with a low T-cell count (> 100 cells/mm3 and less than or equal to 350 cells/mm^3). Study participants will be followed for 96 weeks after receiving the study drug and will be assessed for adverse events, CD4+ and CD8+ T-cell counts, PD-1 expression, CD8+ T-cell anti-HIV activity, and viral load. If a single dose of pembrolizumab appears to be safe and tolerable, then larger multi-dose and efficacy studies can be planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Pembrolizumab | Experimental | Drug: PembrolizumabParticipants with HIV and CD4+ of 100-350 cells/mm^3 received a single dose of Pembrolizumab 200 mg via intravenous (IV) infusion. |
| Placebo | Placebo comparator | Other: PlaceboParticipants with HIV and CD4+ of 100-350 cells/mm^3 received a single dose of Placebo via intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Individuals must meet all of the following criteria to be eligible for study participation:
- Greater than or equal to 18 years of age.
- Documented HIV-1 infection (eg, positive standard enzyme-linked immunosorbent assay or rapid HIV-1/HIV-2 antibody test with a confirmatory test such as western blot, or documentation of repeated HIV RNA of > 1000 copies/mL). Outside documentation will be acceptable.
- Absolute neutrophil count > 1000/microliter.
- Platelet count > 125,000/microliter.
Key exclusion criteria (24 listed)
- Females who are pregnant or breastfeeding.
- Has used an investigational drug agent or investigational device within 12 weeks of baseline.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Known allergy to any component of the pembrolizumab formulation.
- Systemic steroid therapy or other immunosuppressive therapy in the 3 months prior to enrollment (Inhaled or topical corticosteroids are permitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSingle dose of Placebo given via intravenous (IV) infusion. | Other | Placebo |
| PembrolizumabPembrolizumab is a potent and highly selective humanized monoclonal antibody (immunoglobulin [Ig] G4 kappa isotype) that binds to PD-1, thus blocking the receptor from binding with its ligands. Single dose of Pembrolizumab 200 mg given via intravenous (IV) infusion. | Drug | Drug: Pembrolizumab |
Primary outcome
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events
Time frame: Up to 48 weeks from start of 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28431010Gay CL, Bosch RJ, Ritz J, Hataye JM, Aga E, Tressler RL, Mason SW, Hwang CK, Grasela DM, Ray N, Cyktor JC, Coffin JM, Acosta EP, Koup RA, Mellors JW, Eron JJ; AIDS Clinical Trials 5326 Study Team. Clinical Trial of the Anti-PD-L1 Antibody BMS-936559 in HIV-1 Infected Participants on Suppressive Antiretroviral Therapy. J Infect Dis. 2017 Jun 1;215(11):1725-1733. doi: 10.1093/infdis/jix191.
- Background: PubMed 16921384Day CL, Kaufmann DE, Kiepiela P, Brown JA, Moodley ES, Reddy S, Mackey EW, Miller JD, Leslie AJ, DePierres C, Mncube Z, Duraiswamy J, Zhu B, Eichbaum Q, Altfeld M, Wherry EJ, Coovadia HM, Goulder PJ, Klenerman P, Ahmed R, Freeman GJ, Walker BD. PD-1 expression on HIV-specific T cells is associated with T-cell exhaustion and disease progression. Nature. 2006 Sep 21;443(7109):350-4. doi: 10.1038/nature05115. Epub 2006 Aug 20.
- Derived from this study: PubMed 31694954Henderson LJ, Reoma LB, Kovacs JA, Nath A. Advances toward Curing HIV-1 Infection in Tissue Reservoirs. J Virol. 2020 Jan 17;94(3):e00375-19. doi: 10.1128/JVI.00375-19. Print 2020 Jan 17.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Human data generated in this study will be shared for future research as follows: Identified data in the Biomedical Translational Research Information System (BTRIS; automatic for activities in the CC). De-identified or identified data with approved outside collaborators under appropriate agreements. Through publication and/or public presentations. Data sharing may be complicated or limited in certain cases by contractual obligations or agreements with outside collaborators, such as a cooperative research and development agreements, clinical trial agreements, other restraints, etc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Kovacs, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab in people with Human Immunodeficiency Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Either Grade 2 or Higher Autoimmune Events and Grade 3 or Higher Adverse Events (time frame: Up to 48 weeks from start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03367754, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.