A5372

Not Applicable

Not yet recruiting

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

• Registration Number: PER-072-20
• 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: 2021-01-26
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

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

Inclusion Criteria

- Males and females at least 18 but no more than 65 years of age at study entry
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
- Weight ≥40 kg and a body mass index (BMI) of greater than 18.5 kg/m2.
- Documentation of HIV-1 infection status, as below: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E/CIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- HIV-1 plasma viral load <50 copies/mL obtained within 30 days prior to study entry.
- Indication for LTBI treatment according to WHO latent TB guidelines
- On a stable once daily DTG (50 mg) based ART with once daily 2 NRTIs and
• with at least 28 total days of DTG and NRTI dosing prior to study entry • with no gaps in self-reported DTG and NRTI adherence of more than 3 consecutive days in the 28 days prior to study entry • with no intention to change ART for the duration of the study.
- Chest radiograph or chest computed tomography (CT) scan performed within 30 days prior to study entry without evidence of active TB.
- The following laboratory values obtained within 30 days prior to study entry that operates in accordance with GCLP
• Absolute neutrophil count (ANC) >750 cells/mm3 • Hemoglobin ≥7.4 g/dL • Platelet count ≥50,000/mm3 • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ ULN • Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ ULN • Total bilirubin ≤1.5 x ULN .
- For females of reproductive potential, negative serum or urine pregnancy test at Screening within 30 days prior to entry and within 48 hours prior to entry by a laboratory or clinic that operates in accordance with GCLP.
- Female participants of reproductive potential must agree not to participate in the conception process (i.e., active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must agree to use one reliable nonhormonal method of contraception, as listed below, while on study treatment and through study completion. Acceptable forms of contraception include: • Intrauterine device (IUD) or intrauterine system • Cervical cap with spermicide • Diaphragm with spermicide

Exclusion Criteria

- Breastfeeding, pregnancy, or plans to become pregnant.
- Known allergy/sensitivity or any hypersensitivity to components of the study drugs, or their formulations.
- Presence of any confirmed or probable active TB based on criteria listed in the current ACTG Diagnosis Appendix at screening.
- History of rifamycin-monoresistant, INH-monoresistent, multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry.
- Known exposure to rifamycin-monoresistant, INH-monoresistant, MDR- or XDRTB (e.g., household member of a person with rifamycin-monoresistant, INH-monoresistant, MDR- or XDR-TB) at any time prior to study entry by participant self report or medical records.
- Within 30 days prior to study entry, current diagnosis of peripheral neuropathy Grade ≥2
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 7 days prior to study entry.
- Known cirrhosis, a history of decompensated liver disease (ascites, hepatic encephalopathy, or esophageal varices) or current Child Pugh Class B or C hepatic impairment.
- Initiated, discontinued, or changed doses of drugs that are P-glycoprotein (PGP) inducers, that are P-glycoprotein (PGP) inhibitors,or that are known to have drug interactions with DTG, within 30 days prior to study entry
- Known porphyria at any time prior to study entry.
- Receipt of any other antiretroviral therapy other than DTG and 2 NRTI within 28 days prior to study entry.
- Receipt of TAF (tenofovir alafenamide) within 28 days prior to study entry.

Study & Design

• Study Type: Interventional
• Study Design: Not specified