Atazavanir/Ritonavir-based HAART in Children

HIV Clinical Trial

Official title:

The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656109
• Other study ID #: HIV-NAT 146
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2012
• Last updated: August 25, 2014
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.

Description:

Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART have been commonly prescribed as the first-line HAART for HIV-infected children in resource-limited settings. Protease inhibitor (PI)-based HAART are the recommended second-line regimen after failing NNRTI-based HAART. The most commonly used PI in Thailand is lopinavir/ritonavir (LPV/r). However, the metabolic complications of lopinavir/ritonaive (LPV/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for HIV-infected children as it may contribute to the development of cardiovascular disease in the longer term. There are data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected adults but none in children. Furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. As a result of this, this study investigated the efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. HIV-infected children

2. Age from 6- 18 years old

3. Body weight = 25 kg at screening visit

4. ARV history, the children can be categorized in one of these 2 groups

5. ALT <200 IU/L at screening visit

6. Total bilirubin < 3 mg/dL at the screening visit

7. Can swallow capsule

8. Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)

Exclusion Criteria:

1. Active opportunistic infection

2. Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.

3. Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)

4. Pregnancy or lactating at screening visit

5. Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis

6. Inability to understand the nature and extent of the study and the procedures required.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• boosted atazanavir (ATV/r)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline

Locations

Country	Name	City	State
Thailand	Department of Pediatrics Faculty of Medicine, Chulalongkorn University	Bangkok
Thailand	Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	amfAR, The Foundation for AIDS Research, National Health Security Office, Thailand, The Thai Government Pharmaceutical Organization (GPO)

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Bunupuradah T, Techasaensiri C, Keadpudsa S, Thammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T; HIV-NAT 146 Study Team. Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics of atazanavir/ritonavir (ATV/r)	Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed	48 weeks	No
Secondary	CD4	Assess CD percent and count at week 48	48 weeks	Yes
Secondary	plasma viral load (HIV RNA)	assess HIV RNA at week 24 and 48	48 weeks	Yes
Secondary	hyperbilirubin	evaluate total and direct bilirubin at weeks 24 and 48	48 weeks	Yes

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)