A5354/EARLIER (EARLY ART TO LIMIT INFECTION AND ESTABLISHMENT OF RESERVOIR)

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-017-17
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-27
• Study Completion: 2019-11-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1.Appropriate documentation from medical records of diagnosis of AHI within 7 days prior to enrollment, that includes one of the following:

a)A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry

b)A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative/indeterminate WB or negative/indeterminate Geenius HIV-1/HIV-2 Supplemental Assay within 7 days prior to entry

c)A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry

d)ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry

e)ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S/CO <0.5 within 90 days prior to entry

f)ARCHITECT or GSCOMBO S/CO >0.5 but <10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry

2.Men and women age 18 years.

3.Ability and willingness of candidate to provide written informed consent.

4.Ability and willingness to initiate ART at enrollment.

5.Ability and willingness to participate in scheduled study visits for up to 72 weeks.

.6.Female candidates of reproductive potential who are not pregnant at the time of enrollment will receive the study-provided EVG/COBI/FTC/TAF and must agree not to participate in the conception process (ie, active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female candidate must agree to use at least one reliable form of contraceptive while receiving study-provided treatment.

Female candidates who are not of reproductive potential or whose male partner(s) has documented azoospermia are not required to use contraceptives. Any statement of self-reported sterility or that of her partner must be entered in the source documents.

Female candidates who are prescribed a non-study-provided ARV regimen should discuss the safety of that regimen during conception and pregnancy with the prescribing physician. Such individuals should follow medical guidance regarding any potential need for contraception while using the non-study-provided ARV regimen.

Exclusion Criteria

1. Positive HIV-1 antibody test ≥90 days prior to study entry.
2. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
3. 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.
4. Receipt of an investigational study agent within 28 days prior to enrollment
5. Chronic or recurrent use of medications that modify host immune response, eg, oral or parenteral steroids, cancer chemotherapy.
6. AHI diagnosis within 60 days after receiving any investigational ARV or HIV-1 vaccine or immune prophylaxis for HIV-1 infection.
7. Initiation of ARVs for pre- and post-exposure prophylaxis within 60 days prior to the diagnosis of AHI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified