ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1, Single Dose Study of the Safety and Virologic Effect of an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously to HIV-Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02840474
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

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. Enrollment in Part A of the study is finished. In Part B, the researchers are studying VRC07-523LS. Depending on which antibody received, they will study the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They will check 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. Females who are able to get pregnant must be willing to use birth control during the study.

Design:

Participants will get the study drug one time, by IV infusion. A needle will guide a thin tube into a vein. The study drug mixed with salt water will be dripped into the vein over about 30 minutes.

Participants will be monitored for 30 minutes after the infusion.

Blood samples will be 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 3 optional blood draws in the time period between 4 and 24 hours.

For 3 days after the infusion, participants will write their temperature and symptoms in a diary.

There will be a total of 23 study visits over 48 weeks. Ten visits will be in the first 4 weeks. At all visits, participants will answer health questions and give blood samples.


Condition or disease Intervention/treatment Phase
HIV-1 Biological: VRC-HIVMAB080-00-AB (VRC01LS) Biological: VRCHIVMAB075 00 AB (VRC07 523LS) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VRC 607-ACTG A5378: A Phase 1, Single Dose Study of the Safety and Virologic Effect of an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS) or VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously to HIV-Infected Adults.
Study Start Date : July 19, 2016
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 1
This study will assess VRC01LS or VRC07 523LS administered at 40 mg/kg IV in HIV infected viremic participants.
Biological: VRC-HIVMAB080-00-AB (VRC01LS)
VRC01LS and VRC07 523L are investigational human monoclonal antibodies that target the CD4 binding site of HIV 1. VRC01LS and VRC07 523LS are modifications of the VRC01 monoclonal antibody with the addition of the "LS".

Experimental: 2
This study will assess VRC01LS or VRC07 523LS administered at 40 mg/kg IV in HIV infected viremic participants.
Biological: VRCHIVMAB075 00 AB (VRC07 523LS)
VRC01LS and VRC07 523L are investigational human monoclonal antibodies that target the CD4 binding site of HIV 1. VRC01LS and VRC07 523LS are modifications of the VRC01 monoclonal antibody with the addition of the "LS".




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of VRC01LS or VRC07 523LS administered at 40 mg/kg IV to HIV 1 infected viremic adults. [ Time Frame: Through 48 weeks of study participation. ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics of VRC01LS or VRC07 523LS at 40 mg/kg IV through the first 48 weeks post administration. [ Time Frame: Through the first 48 weeks post administration. ]
  2. To evaluate the effect on CD4 count and viral load through study week 48. [ Time Frame: Through the first 48 weeks post administration. ]
  3. To determine whether anti drug antibody (ADA) to VRC01LS or VRC07 523LS can be detected postadministration [ Time Frame: Through the first 48 weeks post administration. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

A participant must meet all of the following criteria:

  1. Able and willing to complete the informed consent process.
  2. 18-70 years old
  3. Available for clinic visits for 48 weeks after study product administration.
  4. HIV-1 infected and clinically stable. [Note: Documented HIV-1 infection by HIV enzyme immunoassay (EIA) performed by a CLIA certified outside lab within 28 days of enrollment is acceptable.]
  5. 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].
  6. A CD4+ count >=350 cells/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].
  7. 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.
  8. Willing to have blood samples collected, stored indefinitely, and used for various research purposes.
  9. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  10. 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
    • ALT less than or equal to 2.5 x 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:

  11. 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.
  12. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

EXCLUSION CRITERIA:

A participant will be excluded if one or more of the following conditions apply:

  1. Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
  2. Prior use of antiretroviral therapy.
  3. Ongoing AIDS-related opportunistic infection (including oral thrush).
  4. Active drug or alcohol use or dependence in the opinion of the site investigator that would interfere with adherence to study requirements.
  5. 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.
  6. Physical finding on examination considered clinically significant.
  7. Hypertension that is not well controlled.
  8. Weight >115 kg (253 pounds).
  9. Breast-feeding.
  10. Receipt of any investigational study product within 28 days prior to enrollment.
  11. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840474


Contacts
Contact: VRC Clinic (301) 451-8715 vaccines@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: VRC Clinic    301-451-8715    vaccines@nih.gov   
AIDS Clinical Trials Group (ACTG) Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Pablo Tebal, MD    301-628-3000    actg.teama5378@fstrf.org   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Grace L Chen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02840474     History of Changes
Other Study ID Numbers: 160147
16-I-0147
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 21, 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
HIV Viral Load
Antiviral
CD4 Count
HIV-1 Infection

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs