ATI HVTN804/HPTN095

Phase 1

Recruiting

• Conditions: -Z21 Asymptomatic human immunodeficiency virus [HIV] infection status; Asymptomatic human immunodeficiency virus [HIV] infection status; Z21

• Registration Number: PER-092-20
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-03
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Estimated date of HIV-1 acquisition within 8 weeks of participant’s last HVTN 704/HPTN 085 infusion.
2. Initiated ART within 28 weeks of HVTN 704/HPTN 085 HIV-1 date of diagnosis.
3. Receiving continuous ART for at least 1 year
4. If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
5. Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
6. Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
7. Willingness to use barrier protection (ie, male or female condoms) for all sexual activity until after confirmation of viral suppression following ART reinitiation
8. Willingness for CRS staff to contact primary HIV care provider to exchange information regarding HVTN 804/HPTN 095 and participant medical history.
9. Site investigator anticipates that a fully active alternative ART regimen could be constructed and would be available in the event of virologic failure on the participant’s current ART regimen.
10. Access to a participating CRS and willingness to adhere to study visit schedule and to be followed for the planned duration of the study.
11. Ability and willingness to provide informed consent.
12. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
13. Agrees not to enroll in another study of an investigational research agent for the duration of the participant’s trial participation.
14. HIV-1 infection, with reactive HIV-1 antibody and any Multispot or Geenius HIV-1/HIV-2 results, documented by the HVTN 704/HPTN 085 HIV diagnostic algorithm.
15. Plasma HIV-1 RNA ≥ 1,000 copies/mL by any assay, prior to initiating ART.
16. CD4+ cell count ≥ 450 cells/mm3 obtained within 90 days prior to enrollment.
17. One plasma HIV-1 RNA below the lower limit of quantitation (LLOQ) collected at each of the following:
Note:Non-US sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.
18. Hemoglobin (Hgb) ≥ 10.0 g/dL for volunteers who were assigned female sex at birth, ≥ 11.0 g/dL for volunteers who were assigned male sex at birth.
19. Absolute neutrophil count (ANC) ≥ 750 cells/mm3
20. Platelets ≥ 100,000 cells/mm3
21. ALT < 2.5 times the institutional upper limit of normal and direct bilirubin within the institutional range of normal.
22. Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2.
23. Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed at the screening visit and prior to enrollment. Persons who are NOT capable of becoming pregnant due to having reached menopause (no menses for 1 year) or having undergone total hysterectomy or bilateral oophorectomy or tubal ligation (verified by medical records) are not required to undergo pregnancy testing.
24. Reproductive status: A volunteer who is capable of becoming pregnant must agree to consistently use effective contraception (see Appendix B and HVTN 804/HPTN 095 SSP) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through confirmation

Exclusion Criteria

1. Any plasma HIV-1 RNA ≥ LLOQ (LLOQ: 75, 50, 40, or 20 copies/mL) within 12 months prior to enrollment.
Note: Non-US sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.
2. History of AIDS-defining illnesses or US Centers for Disease Control (CDC) Category C events per the current list on the CDC website (see HVTN 804/HPTN 095 SSP).
3. Autoimmune disease, including Type I diabetes mellitus.
4. Immunosuppressive medications received within 6 months before enrollment.
5. Blood products received within 120 days before planned ART interruption.
6. Investigational research agents, other than experimental vaccine(s), received within 30 days before planned ART interruption.
7. HIV or non-HIV experimental vaccine(s) received within the last 1 year.
8. Licensed live attenuated vaccines received within 30 days before planned ART interruption (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine).
9. Licensed vaccines that are not live attenuated vaccines received within 14 days before planned ART interruption (eg, tetanus, pneumococcal, hepatitis A or B).
10. Significant or unstable cardiac or cerebrovascular disease (eg, angina, congestive heart failure [CHF], recent cerebrovascular accident [CVA], or myocardial infarction [MI]).
11. Hepatitis B surface antigen (HBsAg) or positive HCV RNA (Not exclusionary: positive HCV Ab with negative HCV RNA).
12. Pregnant or breastfeeding
13. Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: • A process that would affect the immune response; • A process that would require medication that affects the immune response; • Any contraindication to repeated blood draws, including inability to establish venous access; • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer’s health or well-being during the study period; or • Any condition specifically mentioned among the exclusion criteria.
14. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a volunteer’s ability to give informed consent.
15. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, could be exacerbated by events associated with protocol participation, which include: ATI, low-level viremia, subsequent viral rebound, and ART re-initiation.
16. HIV dementia or other neurologic disease that, in the judgment of the investigator, would be a contraindication to study participation.
17. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
18. Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator’s judgment, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of mal

Study & Design

• Study Type: Interventional
• Study Design: Not specified