PK SUBSTUDY OF A5263 AND A5264

PHARMACOLOGY SUBSTADIES OF A5263 AND A5264

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-026-14

Enrollment

Registered

2014-05-22

Start date

2014-04-30

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

This substudy will coenroll a subset of participants randomized on ACTG parent studies A5263 and A5264 for PK sampling on no more than two occasions.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Women and men participants of A5263 and A5264 that accomplished with the following criteria: Inclusion Criteria Step 1 1. Current enrollment in Arms 1A, 1B, or 1C of A5263 or Arms 1A or 1B of A5264. 2. Participant must be able to complete PK sampling within the following acceptable windows: • For A5263 Arm 1A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen). • A5263 Arm 1B, PK sampling will be performed at a protocol scheduled clinic visit on first dosing day of 2nd BV cycle (with concomitant administration of the ART regimen). PK sampling may be performed on first dosing day of 1st BV cycle if participant has been receiving EFV/TDF/FTC for at least 5 days. • For A5263 Arm 1C, PK sampling will be performed at a protocol scheduled clinic visit on dose day of 2nd PTX cycle (with concomitant administration of the ART regimen). PK sampling may be performed on dose day of 1st PTX cycle if participant has been receiving EFV/TDF/FTC for at least 5 days. • For A5264 Arm 1A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) after the start of the ART regimen. • For A5264 Arm 1B, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen). 3. Current use of EFV/TDF/FTC. 4. Ability and willingness of participant or legal guardian/representative to provide informed consent Inclusion Criteria Step 2 1. Current enrollment in Step 2 of A5264. 2. Participant must be able to complete PK sampling within the following acceptable windows: • For A5264 Arm 2A, PK sampling will be performed at a protocol scheduled clinic visit on day 6 (+ 1 day) of the first cycle of ET administration (with concomitant administration of the ART regimen). 3. Current use of EFV/TDF/FTC.

Exclusion criteria

Exclusion criteria: Not applicable, the participants are the main study

Countries

Brazil, Kenya, Malawi, Peru, South Africa, Uganda, Zimbabwe

Contacts

Public ContactAldo Javier Lucchetti

ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION

alucchetti@impactaperu.org562-1600

Outcome results