Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    74
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 18 April 2021
local anesthetic
hysterectomy
hiv test
hepatitis
hiv viral load
protease
reverse transcriptase inhibitor
integrase inhibitors
HIV Vaccine
antiviral drugs
immune globulin
antibody test
viremia
hiv-1 infection
hiv-1 rna measurement
hiv-1 antigen

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody,VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.

Description

This study will assess the safety, tolerability, pharmacokinetics, and antiviral activity of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.

The study will be conducted in three steps. At Step 1 entry, all participants will discontinue their current antiretroviral therapy (ART) regimen except for nucleoside reverse transcriptase inhibitors (NRTIs), and initiate oral CAB.

During Step 1, participants tolerating oral CAB plus their current two NRTIs, and displaying viral suppression (HIV-1 RNA <50 copies/mL), will register to Step 2. At entry into Step 2, eligible participants will stop their oral CAB and NRTIs and will receive a VRC07-523LS infusion plus CAB LA injection. After entry in Step 2, participants will receive CAB LA every 4 weeks through Week R2+44 plus VRC07-523LS every 8 weeks through Week R2+40.

At the last visit in Step 2 (Week R2+48), or at premature study treatment discontinuation, all participants who received any CAB LA or VRC07-523LS will enter Step 3 and switch to standard of care (SOC) oral ART for approximately 48 weeks.

Participants will attend a number of study visits throughout the study. Study visits may include a physical examination, clinical assessment, pregnancy testing, and blood and urine collection. Participants will remain in the study for up to 101 weeks, including approximately 5 weeks in Step 1, 48 weeks in Step 2, followed by 48 weeks in Step 3.

Details
Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Treatment VRC07-523LS, Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Oral Cabotegravir (CAB), Long-Acting Injectable Cabotegravir (CAB LA), Standard of Care (SOC) Oral ART
Clinical Study IdentifierNCT03739996
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Primary Immunodeficiency Disorders or HIV Infections or HIV infection or Immunodeficiency?
Do you have any of these conditions: Primary Immunodeficiency Disorders or HIV Infections or HIV infection or human immunodeficiency virus or hiv disease or Immunodeficiency?
Do you have any of these conditions: Primary Immunodeficiency Disorders or Immunodeficiency or human immunodeficiency virus or hiv disease or HIV infection or HIV Infections?
Do you have any of these conditions: Immunodeficiency or HIV Infections or HIV infection or Primary Immunodeficiency Disorders or hiv disease or human immunodeficiency virus?
HIV-1 RNA less than 50 copies/mL at week 4 (Step 1), or HIV-1 RNA of 50-199 copies/mL at week 4 followed by HIV-1 RNA less than 50 copies/mL at week 5 (Step 1)
Females of reproductive potential must have a negative serum or urine pregnancy test obtained within 48 hours prior to Step 2 registration
NOTE: Refer to the criteria above for definition of reproductive potential and acceptable documentation
Confirmation that female participant agrees to continue to use an effective form of contraception (see criterion above) while on study, and for approximately 48 weeks after last dose of CAB LA or VRC07-523LS
Confirmation of willingness to not actively engage in the conception process for the duration of the study

Exclusion Criteria

Discontinuation or temporary hold of oral CAB for greater than 7 consecutive days for any reason during Step 1
Discontinuation or temporary hold of NRTIs for greater than 7 consecutive days for any reason during Step 1
Grade 3 or 4 adverse event thought to be related to oral CAB during Step 1 according to the site investigator
Vaccination (e.g., influenza) within 7 days prior to the Step 2 registration
Currently breastfeeding or pregnant
Any greater than or equal to Grade 2 ALT (greater than 2.5 times ULN) that developed during Step 1
Current implants and/or direct silicone injections on or around the subcutaneous area where the study product will be administered
An overlying tattoo (that is located on or around the skin area where the study product will be administered) that, per the site investigator's best clinical judgement, would impede clinical care or management in any way
Step 3 Inclusion Criterion
Received any CAB LA or VRC07-523LS during Step 2
NOTE: Participants who prematurely discontinue study treatment for any reason in Step 2 remain eligible for Step 3
Step 3 Exclusion Criterion
There are no exclusion criteria to Step 3
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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