Resistance to Protease Inhibitor Regimens in Africa: Sample Collection for Exploratory Use (INSPIRE)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202505581692297

Enrollment

100

Registered

2025-05-05

Start date

2024-09-02

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

HIV/AIDS

Interventions

Phenotypic drug susceptibility assay

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (=18 -54 years); 2. HIV-positive; 3. Taking protease-inhibitor containing antiretroviral therapy; 4. Viral load draw within the past calendar year; 5. Able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Unwilling to provide a blood sample.

Design outcomes

Primary

Measure	Time frame
•To evaluate HIV-1 drug resistance outside classical targets (i.e., pol gene) in those with viral breakthrough on a boosted protease inhibitor (PI/r) regimen. •To determine the virological basis for treatment failure in patients where PI/r resistance is not predicted by standard genotypic tests and correlate HIV resistance genotypes, phenotypes and clinical outcomes in patients infected with non-B HIV-1 subtypes. •To compare results across several viral clades.	—

Measure

Time frame

•To evaluate HIV-1 drug resistance outside classical targets (i.e., pol gene) in those with viral breakthrough on a boosted protease inhibitor (PI/r) regimen. •To determine the virological basis for treatment failure in patients where PI/r resistance is not predicted by standard genotypic tests and correlate HIV resistance genotypes, phenotypes and clinical outcomes in patients infected with non-B HIV-1 subtypes. •To compare results across several viral clades.

—

Countries

South Africa

Contacts

Public ContactDaphne Moralie

Operations and Project Manager

Daphne.Moralie@hiv-research.org.za+27213012020

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026