Combination Therapy With VRC-HIVMAB060-00-AB (VRC01) and 10-1074 in HIV-Infected Individuals Undergoing Sequential Treatment Interruptions

  • End date
    Mar 31, 2024
  • participants needed
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 22 July 2020
Catherine A Seamon, R.N.
Primary Contact
National Institutes of Health Clinical Center (9.7 mi away) Contact
platelet count
HIV Infection
antiretroviral agents
antiretroviral therapy
direct bilirubin
hiv-1 infection



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 can also develop resistance or permanent side effects. Researchers want to see if 2 new drugs can help control HIV when a person is not on ART.


To see if VRC01 and 10-1074 are safe and control HIV when a person is not on ART.


Adults 18 65 with HIV


All participants must agree to practice safer sex. Those who can get pregnant will have a pregnancy test every visit.

Participants will be screened with:

Physical exam

Medicine review

Blood and urine tests

Some participants may need to change their HIV medicine for a brief period of time during the study.

A few weeks later, participants will repeat screening tests and stop taking their HIV medicines.

Interruption phase 1: Participants will have blood tests every 2 weeks, and repeat screening tests every 4 weeks.

Treatment phase: Once their HIV reaches a certain level in the blood, participants will get the 2 study drugs or a salt water placebo. They will not know which they get. Each substance will be given through a thin tube in an arm vein for about 1 hour. Participants will restart their HIV medicines and repeat screening tests every 4 weeks.

Interruption phase 2: Once the level of HIV in the blood becomes undetectable for 3 months, participants will again stop taking their HIV medicines and have blood tests every 2 weeks to monitor the level of HIV in the blood.

Participants will restart their medicines by week 24. They will start sooner if they have certain symptoms or blood levels of HIV become too high. They will repeat most screening tests 3 times over 24 weeks.


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 (bNAbs) from B cells of HIV-infected individuals. It has been shown that certain bNAbs can prevent acquisition of the virus, suppress viral replication, delay and/or prevent plasma viral rebound following treatment interruption in simian/human immunodeficiency virus (SHIV)-infected animals. Preliminary data from clinical trials indicates that bNAbs may delay plasma viral rebound following interruption of antiretroviral therapy (ART) and block cell-to-cell transmission of laboratory-adapted HIV in vitro.

In the above studies, suppression of plasma viremia was dependent on maintaining neutralizing serum levels of bNAbs via repeated intravenous (IV) infusions. A recent pre-clinical study in an acute SHIV-macaque model suggests a limited course of passive immunotherapy with two bNAbs (10-1074 and 3BNC117) given shortly after infection, can result in prolonged suppression of plasma viremia that is not dependent on the continuous presence of the bNAbs18. Based on CD8+ T cell depletion studies, it appears that the prolonged suppression of plasma viremia observed in these animals resulted from the induction of potent antiviral CD8+ T cell immunity by the short course bNAb treatment. The mechanism by which bNAb therapy could induce such a response is unclear but could involve the early formation of unique bNAb-SHIV immune complexes that subsequently induce an effective and durable T cell response to the virus.

In light of these encouraging preclinical outcomes, it is of considerable interest to investigate whether treatment with a single infusion of two bNAbs (VRC01 and 10-1074) which target different epitopes of HIV gp120 (CD4 binding site and V3 glycan, respectively), during transient plasma viremia can induce long-lasting anti-HIV immunity capable of controlling plasma viremia in the absence of ART.

Treatment Normal Saline Placebo, 10-1074, VRC-HIVMAB060-00-AB (VRC01)
Clinical Study IdentifierNCT03831945
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on22 July 2020

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Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: HIV positive or HIV (Pediatric) or HIV or HIV infection or HIV Infections or AIDS Vaccines?
-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
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
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 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 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
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