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MERLIN Study

Not Applicable
Recruiting
Conditions
-B24 Unspecified human immunodeficiency virus [HIV] disease
Unspecified human immunodeficiency virus [HIV] disease
B24
Registration Number
PER-054-16
Lead Sponsor
FRED HUTCHINSON CANCER RESEARCH CENTER,
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Male
Target Recruitment
46
Inclusion Criteria

(1) Age ≥18 years; (2) MSM or TW; (3) Able to give consent for medical procedures, blood draws, and switching antiretroviral medication if indicated; (4) Participants with acute/recent HIV infection will have participated in ¿SABES?; (5) Acute/Recent HIV Participants: already on ART, without treatment interruption, either: receiving co-formulated EFV/FTC/TDF or receiving co-formulated EVG/COBI/FTC/TDF; or receiving a combined ART regimen sponsored by the Peruvian MOH or prior/current participation in SABES? and now receiving a non-EFV or EVG regimen; (6) Kidney, liver, and hematologic functions should not prohibit ongoing administration of study drugs; (7) No medical or psychiatric conditions that render the person a poor study participant in the opinion of the study physician; and (8) Co-enrollment with other protocols will be at the investigators discretion.

Exclusion Criteria

(1) Chronic hepatitis B co-infection; (2) Use of drugs that are highly dependent on CYP3A for clearance (such as rifampin) which preclude administration of one of the study ART regimens or else other clinically-indicated 3-drug ART regimen; (3) Concurrent use of aminoglycosides, IV amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, probenecid, adefovir or immunomodulatory agents; or (4) Any other medical or social condition that in opinion of the investigator, could affect the assessment of study objectives or put volunteers at risk.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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