Status and phase
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Treatments
About
A5388 is a phase II, two-arm, randomized, double-blind, placebo-controlled study that will enroll 48 antiretroviral therapy (ART)-naïve adults with acute HIV infection (AHI) in order to determine whether:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Step 1:
Appropriate documentation from medical records of diagnosis of AHI prior to enrollment that includes one of the following:
The following laboratory values obtained within 21 days prior to entry:
Absolute neutrophil count (ANC) ˃1,000/mm3
Hemoglobin:
Platelet count ˃100,000/mm3
Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation, with consideration for lower rates in special circumstances.
ALT (SGPT) ≤2.5 x ULN
AST (SGOT) ≤2.5 x ULN
Total bilirubin <1.5 x ULN
For persons who are able to become pregnant, negative urine or serum pregnancy test within 24 hours prior to study entry.
Persons who are able to become pregnant must agree to use two methods of contraception throughout Step 1 if participating in sexual activity that could lead to pregnancy. One contraceptive method must be a highly effective method and the second method of contraception must be a barrier method.
Participants of reproductive potential who engage in sexual activity that could lead to their partner's becoming pregnant must agree to use a barrier method of contraception throughout Step 1.
Ability and willingness to use a barrier method or abstinence from sexual intercourse with all partners who are vulnerable to HIV or whose HIV serostatus is unknown in order to prevent HIV transmission during Step 2, Step 3, and until plasma HIV-1 RNA is less than the limit of detection after ART restart in Step 4.
Age ≥18 and ≤70 years.
Ability and willingness to initiate ART at enrollment.
Ability and willingness to participate in scheduled study visits, including during the ATI, per Schedule of Evaluations (SOE).
Ability and willingness of participant to provide informed consent.
Step 2:
Step 3:
Step 4:
Exclusion criteria
Step 1:
Previous receipt of immunoglobulin (IgG) therapy.
Previous receipt of humanized or human monoclonal antibody whether licensed or investigational (other than for the prevention and/or treatment of SARS-CoV-2/COVID-19).
History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.
History of chronic urticaria requiring daily treatment.
Receipt of investigational study agent within 28 days prior to enrollment.
Past participation in an investigational study of a candidate HIV vaccine or immune prophylaxis for HIV-1 infection with receipt of active product or with receipt of active product or placebo and remains blinded to what they actually received.
Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months.
Use of any immunomodulatory medications within 6 months of study entry including systemic corticosteroids (long-term), immunosuppressants, anti-cancer, interleukins, systemic interferons, systemic chemotherapy, or other medications that the site investigator feels could have an immune modulatory effect.
Use of ART for any reason, including pre- or post-exposure prophylaxis, within 60 days prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Known history of active Hepatitis B or Hepatitis C infection.
Any acute, chronic, or recent and clinically significant medical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements or jeopardize the safety or rights of the participant.
History of or current clinical atherosclerotic cardiovascular disease (ASCVD) as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:
Currently breastfeeding or pregnant.
Weight >115 kg.
Use of prohibited medications for bictegravir, emtricitabine, and tenofovir alafenamide (refer to protocol section 5.8) within 7 days prior to entry, or planned use of prohibited medications during the period of study participation.
Absence of adequate venous access for the administration of infusion or for phlebotomy to assess for the primary study endpoint.
Step 2:
Step 3:
Step 4:
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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