Status:
TERMINATED
Combination Therapy With VRC01 and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Background: A daily drug combination can keep human immunodeficiency virus (HIV) levels low for a long time. But if this combination antiretroviral therapy (ART) stops, HIV levels go back up. People ...
Detailed Description
Recent advances in antibody cloning technologies have led to the development of a number of highly potent and human immunodeficiency virus (HIV)-specific broadly neutralizing monoclonal antibodies (bN...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 18-65 years of age.
- HIV-1 infection and clinically stable.
- General good health and has an identified primary health care provider for medical management of HIV infection and is willing to maintain a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
- CD4+ T cell count \>450 cells/mm(3) at screening.
- Documentation of continuous ART treatment with suppression of plasma viral level below the lower limit of quantification (LLOQ) for the assay used for greater than or equal to 2 years. Individuals with blips (i.e., detectable viral levels on ART) prior to screening may be included provided they satisfy the following criteria:
- The blips are \<400 copies/mL, and
- Succeeding viral levels return to levels below the limit of detection on subsequent testing.
- Laboratory values within pre-defined limits at screening:
- Absolute neutrophil count \>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).
- Estimated or a measured glomerular filtration rate \>60 mL/min/1.73 m(2) as determined by the NIH Clinical Center (CC) laboratory.
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) levels of \<2.5 times upper limit of normal (ULN), direct bilirubin within the normal range for the NIH CC laboratory.
- Willingness to have samples stored for future research.
- Willingness to undergo analytical treatment interruption (ATI)
- Willingness for both male and female subjects to agree to use barrier protection methods or abstinence during the ATI phase of the study to decrease the risk of HIV transmission.
- Reproductive Risks
- Contraception: The effects of VRC01 and 10-1074 on the developing human fetus are unknown. For this reason, men and women of childbearing potential must agree to use adequate pregnancy prevention. This includes the use an effective method of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting intrauterine device (IUD), hormone-based contraceptive with condom) for the study duration. Subjects should also agree to use a male or female condom while off ART. Pregnancy prevention must be practiced continuously for the duration of study participation. Females of childbearing-age must have a negative pregnancy test result prior to receiving the infusions of VRC01 and 10-1074/placebo. During the course of the study, if a female subject, or the partner of a male subject suspects or in fact becomes pregnant, the affected subject should inform the study staff immediately, as well as the woman s primary care physician.
- EXCLUSION CRITERIA:
- Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen (HBsAg), or chronic hepatitis C virus (HCV) infection, as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
- HIV immunotherapy or HIV vaccine(s) received within 1 year prior to screening.
- Any prior history of receiving 10-1074 or VRC01.
- 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 (Exceptions: \[1\] corticosteroid nasal spray or inhaler; \[2\] topical corticosteroids for mild, uncomplicated dermatitis; or \[3\] 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 or cerebrovascular disease (e.g., angina, congestive heart failure, recent stroke or 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.
- Pregnancy or breast-feeding at time of screening.
- Documented multiclass antiretroviral drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study.
Exclusion
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03831945
Start Date
April 4 2019
End Date
December 8 2020
Last Update
October 12 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892