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Pharmacokinetics of Atazanavir in Special Populations

NCT03923231 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2023-05-09

No results posted yet for this study

Summary

The lack of data relating to the DDI between ATV and RIF is a major limitation to the use of ATV in patients who require treatment for TB. The VirTUAL Workpackage 2 will explore the necessary dose escalation required to overcome this interaction in non-pregnant HIV-infected adults who are virologically suppressed on bPI-based ART, and who are administered RIF as a study drug, not as part of a full TB treatment regimen. As the specific objective of WP2 is to define the dose of ATV, participants taking an alternative bPI will be transitioned to ATV for the duration of that study. However, to extrapolate the results of this study to special populations such as pregnant and postpartum women, children and adolescents and those with other 'special' characteristics such as obesity (BMI \>30 Kg/m2) or malnutrition (BMI \<18.5 Kg/m2) we propose to undertake sparse sampling for pharmacokinetic analysis from individuals who require ATV-based ART for their clinical care.

Sparse PK data will be obtained opportunistically from participants in the 'special populations' defined above who are receiving ATV as part of their routine clinical care. Subjects will be identified from clinics including the Joint Clinical Research Center (JCRC) and Infectious Diseases Institute (IDI), Kampala, and from sites including Groote Schuur Hospital and Gugulethu Community Health Centre, Cape Town. The ATV/r data from "special populations" will enable validation and refinement of both the PBPK model (WP1) and the pop-PK models (WP4) of the VirTUAL consortium.

Conditions

Interventions

DRUG

Atazanavir 300mg/ Ritonavir 100 mg once daily

There is no intervention in this study - participants will all be receiving atazanavir (usually boosted with ritonavir) as part of their routine clinical care

DRUG

Atazanavir 250 mg / ritonavir 80 mg

There is no intervention in this study - participants will all be receiving atazanavir (usually boosted with ritonavir) as part of their routine clinical care. This dose of 250/ 80 is for participants weighing between 15 and 25 Kg

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Joint Clinical Research Centre- Kampala

    collaborator UNKNOWN

  • Desmond Tutu HIV Foundation

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP) - funder

    collaborator UNKNOWN

  • University of Liverpool

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2020-05-01
Completion
2022-11-30

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923231 on ClinicalTrials.gov