Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults

Completed · Phase 1

Conditions studied: HIV-1

In brief

Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it. Objective: To see if VRC01LS and VRC07-523LS are safe and well tolerated. Eligibility: Adults ages 18-70 who are HIV infected but otherwise healthy. Design: Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes. Participants were monitored for 30 minutes after the infusion. Blood samples were taken at the following times: * Once before the infusion * 5 times in the 4 hours after the infusion * 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours. For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary. There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.

Key facts

Study ID

NCT02840474

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

16

Starts

2017-04-24

Expected to finish

2020-01-15

Last updated by the study team

2025-01-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A participant must meet all of the following criteria:
• Able and willing to complete the informed consent process.
• 18-70 years old
• Available for clinic visits for 48 weeks after study product administration.
• HIV-1 infected and clinically stable. [Note: Documented HIV-1 infection by HIV enzyme immunoassay (EIA) performed by a Clinical Laboratory Improvement Amendments (CLIA) certified outside lab within 28 days of enrollment is acceptable.]
• At least one plasma viral load >=500 copies/mL within 28 days of enrollment. A plasma viral load within 28 days and closest to the day of enrollment, that is detectable but not greater than 100,000 copies/mL. [Note: outside laboratory results will be acceptable].
• A CD4+ count >=350 cells/microliter (mcL) on 2 of 3 consecutive testing occasions (or on 2 of 2 sequential tests) within 28 days prior to enrollment. [Note: outside laboratory results will be acceptable].
• In general good health as assessed by a study clinician and under the care of a primary health care provider for medical management of HIV infection while participating in the study. Willing to give consent to contact and send laboratory results to the participant's primary health provider.
• Willing to have blood samples collected, stored indefinitely, and used for various research purposes.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Screening laboratory values within 28 days prior to enrollment must meet the following criteria:
• Absolute neutrophil count >=800/mcL
• Platelets >=100,000/mcL
• Hemoglobin >=10.0 g/dL
• Creatinine less than or equal to 1.31 mg/dL
• Alanine aminotransferase (ALT) less than or equal to 2.5 x upper limit of normal (ULN)
• Negative Hepatitis B Surface Antigen (HBsAg)
• Undetectable Hepatitis C Viral Load (HCV RNA)
• [Note: Documented negative HBsAg and HCV RNA performed by an outside CLIA certified lab within 28 days of enrollment are acceptable.]
• Female-Specific Criteria:
• If a woman is sexually active with a male partner and has no history of hysterectomy, tubal ligation, or menopause, she must agree to use either a prescription birth control method or a barrier birth control method from the time of study enrollment until the last study visit, or have a monogamous partner who has had a vasectomy.
• Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

You may not qualify if…

• A participant will be excluded if one or more of the following conditions apply:
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
• Prior use of antiretroviral therapy.
• Ongoing AIDS-related opportunistic infection (including oral thrush).
• Active drug or alcohol use or dependence in the opinion of the site investigator that would interfere with adherence to study requirements.
• Any history of a severe allergic reaction, including generalized urticaria, angioedema or anaphylaxis prior to enrollment, that has a reasonable risk of recurrence during the study.
• Physical finding on examination considered clinically significant.
• Hypertension that is not well controlled.
• Weight >115 kg (253 pounds).
• Breast-feeding.
• Receipt of any investigational study product within 28 days prior to enrollment.
• Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer.

Where it is running

• University of Alabama HIV Clinic Clinical Research Site, AIDS Clinical Trials Group (ACTG) — Birmingham, Alabama, United States
• UCLA CARE Center, AIDS Clinical Trials Group (ACTG) — Los Angeles, California, United States
• Washington University Therapeutics, AIDS Clinical Trials Group (ACTG) — St Louis, Missouri, United States
• University of Cincinnati University Hospital, AIDS Clinical Trials Group (ACTG) — Cincinnati, Ohio, United States
• Ohio State University Clinical Research Site, AIDS Clinical Trials Group (ACTG) — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania Clinical Research Site, AIDS Clinical Trials Group (ACTG) — Philadelphia, Pennsylvania, United States
• Puerto Rico AIDS Clinical Trials Unit, AIDS Clinical Trials Group (ACTG) — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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