a study on HIV/AIDS
The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.
Identification of Biomarkers to Predict Time to Plasma HIV RNA Rebound and Post-Treatment Viral Control During an Intensively Monitored Antiretroviral Pause (IMAP)
For people ages 18–70
Step 1 Inclusion Criteria:
NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies, or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally.
For Cohort B, diagnosis of acute HIV infection (AHI) (as defined by the criteria listed below) and initiation of ART within 45 days after AHI diagnosis (defined as earliest date of positive HIV-1 RNA or antigen/antibody assay).
NOTE: Candidates who were diagnosed with AHI based on this criterion ("c" above) must have had a positive HIV-1 RNA test or subsequently have had a positive Western blot.
NOTE A: ART interruptions of up to 7 days and at least 90 days prior to entry are acceptable.
NOTE B: Within- and between-class changes in ART within the previous 2 years are acceptable.
NOTE: Candidate recall or documentation is acceptable.
FDA-approved assays (limit of detection: 75, 50, 40, or 20 copies/mL) between 12 and 24 months prior to the screening HIV-1 RNA and one documented HIV-1 RNA that is below the limit of detection of the FDA-approved assays (limit of detection: 75, 50, 40, or 20 copies/mL) collected fewer than 12 months prior to the screening HIV-1 RNA.
The following laboratory values obtained within 60 days prior to entry by any US laboratory that is compliant with CLIA or its equivalent or in any network approved non-US laboratory that operates in accordance with GCLP and participates in appropriate EQA programs.
Absolute neutrophil count (ANC) ≥750 cells/mm3 Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women Platelet count ≥100,000/mm3 Creatinine ≤1.5 mg/dL Aspartate aminotransferase (AST) (SGOT) ≤1.5x upper limit of normal (ULN) Alanine aminotransferase(ALT) (SGPT) ≤1.5x ULN
NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, bilateral salpingectomy, tubal micro-inserts, partner who has undergone vasectomy, and menopause is participant-reported history.
Step 1 Exclusion Criteria:
NOTE: A single unconfirmed "blip" (i.e., plasma HIV-1 RNA over limit of detection but <200 copies/mL) is allowed if preceded and followed by values below the limit of detection and if the blip occurred more than 6 months prior to study entry.
NOTE: The entry visit must be scheduled to ensure that 1 week has elapsed after any vaccination.
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03001128.
© The Regents of the University of California