Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV Infections

In brief

Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healthy, HIV-uninfected adults.

Key facts

Study ID

NCT02165267

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

88

Starts

2014-08-01

Expected to finish

2016-02-01

Last updated by the study team

2021-10-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• General and Demographic Criteria
• Weight at least 53 kg and up to 115 kg
• Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: participant demonstrates understanding of this study; completes a questionnaire prior to first infusion, with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Agrees not to enroll in another study of an investigational research agent until completion of the last study visit
• Good general health as shown by medical history, physical exam, and screening laboratory tests
• HIV-Related Criteria
• Willingness to receive HIV test results
• Willingness to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
• Laboratory Inclusion Values
• Hemogram/Complete Blood Count (CBC)
• Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female, greater than or equal to 13.0 g/dL for participants who were born male
• White blood cell count equal to 2,500 to 12,000 cells/mm\^3
• Total lymphocyte count greater than or equal to 800 cells/mm\^3
• Remaining differential either within institutional normal range or with site physician approval
• Platelets equal to 125,000 to 550,000/mm\^3
• Chemistry
• Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to the institutional upper limit of normal
• Virology
• Negative HIV-1 and -2 blood test: U.S. participants must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).
• Negative hepatitis B surface antigen (HBsAg)
• Negative anti-hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
• Urine

You may not qualify if…

• General
• Blood products received within 120 days before first infusion, unless eligibility for earlier enrollment is determined by the HVTN 104 PSRT
• Investigational research agents received within 30 days before first infusion
• Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 104 study
• Pregnant or breastfeeding
• Vaccines and Other Injections
• HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 104 PSRT will determine eligibility on a case-by-case basis.
• Non-HIV experimental vaccine(s) received within the last 6 months in a prior vaccine trial. Exceptions may be made for some vaccines and vaccine trials. For participants who have received an experimental vaccine(s) less than 6 months ago, eligibility for enrollment will be determined by the HVTN 104 PSRT on a case-by-case basis.
• Live attenuated vaccines other than influenza vaccine received within 10 days before first infusion and with no evidence of residual inflammation; or scheduled within 10 days after first infusion (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever).
• Previous receipt of humanized or human monoclonal antibodies (mAbs) whether licensed or investigational
• Immune System
• Immunosuppressive medications received within 30 days before first infusion. (Not excluded: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days, with completion at least 30 days prior to enrollment.
• Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child)
• Immunoglobulin received within 90 days before first infusion, unless eligibility for earlier enrollment is determined by the HVTN 104 PSRT.
• Autoimmune disease (Not excluded: participant with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event [AE] assessments)
• Immunodeficiency
• Clinically Significant Medical Conditions
• Untreated or incompletely treated syphilis infection
• Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• A process that would affect the immune response,
• A process that would require medication that affects the immune response,
• Any contraindication to repeated infusions or blood draws,
• A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period,
• A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
• Any condition specifically listed among the exclusion criteria below.

Where it is running

• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• Fenway Health (FH) CRS — Boston, Massachusetts, United States
• Columbia P&S CRS — New York, New York, United States
• New York Blood Center CRS — New York, New York, United States
• Case Clinical Research Site — Cleveland, Ohio, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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