Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African AdultsLay Title: IAVI C100
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202008822861957
- Lead Sponsor
- International AIDS Vaccine Initiative IAVI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 176
1. Healthy individuals, as assessed by medical history, physical exam, and laboratory tests 2. At least 18 years of age on the day of screening and have not reached their 46th birthday on the day of the first administration 3. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results; committed to maintaining low-risk behavior for the trial duration 4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study; 5. According to the PI/designee and based on Assessment of Understanding results, has understood the information provided and potential impact and/or risks linked to IP administration and participation in the trial; written IC will be obtained from the participant before any study-related procedures are performed; 6. All participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy must commit to using an effective method of contraception from enrollment until 9 months after the last administration, including Condoms, with or without spermicide, IUD & implant Hormonal contraception, Successful vasectomy (male -considered successful if a woman reports that a male partner has; documentation of azoospermia by microscopy (< 1 year ago), or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy) Note: More restrictive measures may be required by study site.
'7. Willing to forgo donations of blood, or any other tissues during the study following confirmation of study eligibility and, for those who test HIV-positive due to antibody-induced seropositivity, until the ant-HIV antibody titers become undetectable on HIV tests used in the community. 8. Body mass index (BMI) >40 9.
1. Confirmed HIV infection; 2. Reported risk for HIV infection within 6 months prior to investigational product administration, as defined by: Unprotected sexual intercourse with a known HIV-infected person, a partner known to be at high risk for HIV infection and/or a casual partner (i.e. no continuing established relationship) Engaged in sex work Frequent excessive daily alcohol use or frequent binge drinking or any other use of illicit drugs History of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B or hepatitis C; Three or more sexual partners; 3. Any clinically relevant abnormality on history or examination, including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted), immunosuppressive, anticancer, antituberculosis or other medications considered significant by the investigator within the previous 6 months; The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrollment in this study; 4. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study; 5. Asthma that is not well controlled; 6. If female, pregnant or planning a pregnancy during the period of enrollment until 9 months after the final IP administration; or lactating; 7. Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability:<br>1. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 2 and above (including confirmed laboratory abnormalities) and their duration.<br>2. Proportion of participants with solicited and IP-related unsolicited adverse events that are Grade 3 and above (including confirmed laboratory abnormalities) and their duration.<br>3. Proportion of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and their duration.<br><br>Pharmacokinetics (PK):<br>4. The ratio of 3BNC117-LS-J to 10-1074-LS-J that, when injected SC, will maintain similar levels of each bNAb at steady state.
- Secondary Outcome Measures
Name Time Method