Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Retroviral Agents; Antibodies; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Able and willing to complete the informed consent process

• Passes Test of Understanding

• 18 to 50 years of age

• Experiencing early acute HIV-1 infection as defined by blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test OR by a positive nucleic acid test or a positive 4th generation enzyme immunoassay (EIA) in the context of a negative 2nd or negative 3rd generation HIV EIA test

• No history of antiretroviral therapy for any indication in the last 30 days.

• In general good health

• Willing to have blood samples collected and stored

• Able to participate for 25 weeks for study visits

• Willing to have photo or fingerprint taken for identification purposes

Female-Specific Criteria:

• Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman has no history of hysterectomy, tubal ligation or menopause, she must agree to use an effective birth control method: abstinence; male or female condoms; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive hormones delivered by pills, patch, injections, or vaginally; and hormonal implants under the skin; or a male partner who has previously undergone a vasectomy.

• Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment for any woman unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy

Exclusion Criteria:

• Weight less than 46 kg or greater than 115 kg

• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational

• Ongoing AIDS-related opportunistic infection (including oral thrush or active tuberculosis)

• Severe acute retroviral syndrome (as defined in Appendix I of the protocol) or clinical condition (other than HIV infection) constituting an indication for immediate antiretroviral therapy per local country guidelines

• Active injection drug use within previous 12 months

• History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment

• History of chronic urticaria

• Physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit

• Hypertension that is not well controlled by medication

• Positive hepatitis B surface antigen at any time in the past

• History of hepatitis C infection

• Untreated syphilis infection

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN).

• Absolute neutrophil count (ANC) less than 740 cells/mm^3

• Estimated glomerular filtration rate (GFR) less than 50 ml/min within the past 90 days

• Breastfeeding

• Pregnancy

• Receipt of licensed vaccine or other investigational study agent within 28 days prior to enrollment or past participation in an investigational HIV vaccine study with receipt of active product

• Current or planned participation in another interventional clinical trial during the study period

• Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy

• Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.

• Study site employee