Phase 1
N=10
VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02471326 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Oct 2017
Primary outcome: Primary: Number of Grade 3 or Higher Adverse Events — 0 Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- VRC-HIVMAB060-00-AB (VRC01) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Grade 3 or Higher Adverse Events |
— | — |
| SECONDARY Subjects Who Met Criteria to Restart Antiretroviral Therapy |
10 | — |
Summary
Background:
- A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART.
Objective:
- To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART.
Eligibility:
- Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks.
Design:
* Participants will be screened with:
* Physical exam
* Medical history
* Heart tests
* Blood and urine tests.
* Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1.
* Visit 1: Repeat screening procedures.
* Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm.
* They will get the first study drug dose through a thin tube in an arm vein for about 1 hour.
* For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis.
* Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.
Eligibility Criteria
- INCLUSION CRITERIA
- Age 18-65 years old.
- HIV-1 infection and clinically stable.
- In general good health and with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
- CD4+ cell count >450 cells/mm^3 at screening.
- Documentation of continuous cART treatment with suppression of plasma viral level below the limit of detection for greater than or equal to 3 years. Subjects with blips (i.e., detectable viral levels on cART) prior to screening may be included provided they satisfy the following criteria:
- The blips are 1,000/mm^3.
- Hemoglobin levels >10.0 g/dL for men and >9.0 g/dL for women.
- Platelet count >100,000/mm^3.
- Prothrombin time (PT) and partial thromboplastin time (PTT) 1 cART regimen.
- HIV immunotherapy or vaccine(s) received within 1 year prior to screening.
- Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment.
- Receipt of other investigational study agent within 28 days of enrollment.
- Any active malignancy that may require systemic chemotherapy or radiation therapy.
- Systemic immunosuppressive medications received within 3 months prior to enrollment (Not excluded: corticosteroid nasal spray or inhaler; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur [length of therapy less than or equal to 10 days, with completion in greater than or equal to 30 days prior to enrollment]).
- History or other clinical evidence of:
- Significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction).
- Severe illness, malignancy, immunodeficiency other than HIV, or any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
- Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Breast-feeding.
Data sourced from ClinicalTrials.gov (NCT02471326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.