Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03239899 : PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
- INCLUSION CRITERIA:

- 18 years or older

- Participation in NIH Protocol 13-N-0149

- Diagnosis of HIV-1 infection, with positive HIV 1 antibody testing

- HIV RNA <40 copies/mL in plasma in the last 12 or greater months

- CD4 count above 350 cells/uL

- Antiretroviral therapy for 12 months prior to trial

- Patient must be willing and able to comply with all the aspects of trial design and
follow-up.

- Patients must be able to provide informed consent

- Participants who are physically able to get pregnant (if applicable: and those who are
able to father a child) must agree to use 2 effective methods of contraception (birth
control) from the time you enroll in the study until 4 months after your last exposure
to pembrolizumab

- Effective methods of contraception for this study include:

- hormonal contraception (birth control pills, birth control patches, injected
hormones, hormonal implants or vaginal ring),

- Intrauterine device,

- Barrier methods (condom or diaphragm) combined with spermicide, and

- Surgical sterilization (hysterectomy, tubal ligation, or vasectomy).

- If you have had a hysterectomy, tubal ligation, or vasectomy (or have a
partner with a hysterectomy, tubal ligation or vasectomy), you do not have
to use 2 methods of birth control.

EXCLUSION CRITERIA:

- Clinically significant medical disorders that might expose the patient to undue risk
of harm confound study outcomes or prevent the patient from completing the study.
Examples of such conditions include cardiac disease such as congestive heart failure,
chronic obstructive pulmonary disease, uncontrolled hypertension, kidney disease,
liver disease, endocrine disease, pulmonary disease, known progressive CNS disease
such as Parkinson s disease, dementia, prior tuberculosis infection or ongoing CNS
opportunistic infection.

- Female sex of reproductive potential (this does not include women who are menopausal,
post-hysterectomy, post-tubal ligation, or other methods of sterilization/inability to
reproduce)

- Patient has received immunomodulatory/immunosuppressive therapy (including IV
steroids) in the preceding 6 months.

- Patient with known autoimmunity that would include but is not limited to disorders
such as hypo/hyperthyroidism, myasthenia gravis, diabetes mellitus type 1, hemolytic
anemia, and immune mediated hepatitis.

- Prior history of cancer (excluding non-invasive squamous and basal cell carcinoma)

- Any opportunistic infection in the prior 2 years (excluding thrush) including latent
TB (or a positive TB Quantiferon Gold test)

- Patient has received other investigational drugs within 3 months before enrollment

- Positive serological or PCR evidence of active or prior infection with HTLV-1/II,
Hepatitis B or C.

- Metal in the body which would make having an MRI scan unsafe, such as pacemakers,
stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves,
cochlear implants or shrapnel fragments, or history of welding or metal worker

- Claustrophobia

- Inability to lie comfortably on the back for up to two hours. Abnormal
screening/baseline blood tests exceeding any of the limits defined below or as deemed
exclusionary by the investigators on review:

- AST and ALT values >1.1x ULN

- Alkaline phosphatase >1.1 x ULN

- Bilirubin >1.1 x ULN

- Creatinine Clearance <60 ml/minute

- Hemoglobin levels < normal range by sex

- Platelet count <130,000/mm^3

- Hemoglobin A1c greater than or equal to 6%

- TSH outside of the normal range

- Any other screening laboratories outside of the normal range with the exception
of phosphorous, magnesium, and D-Dimer.

- An employee or staff of the NIH
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03239899      |      Link to official Clinicaltrials.gov listing
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