A PK and Salvage Study for Children With HIV-infection

HIV Infections Clinical Trial

Official title:

Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476359
• Other study ID #: HIV-NAT 017
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2007
• Last updated: March 26, 2015
• Start date: October 2003
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai children.

Description:

The PK and 24 week data has been published in Pediatric Infectious Diseases Journal. It showed that plasma drug concentrations of saquinavir, lopinavir and ritonavir were at the higher limits of expected ranges for adult treatment at approved dosages (1000/100 mg BID for saquinavir, 400/100 mg BID for lopinavir/r). The regimen was well tolerated and showed significant CD4 rise and VL decline at 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

1. Confirmed HIV-1 infection by HIV-DNA PCR if < 18 months old or by HIV ELISA if greater than or equal to 18 months old

2. Subject is less than or equal to 16 years of age at the day of the first dosing.

3. Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.

4. Results of biochemistry and haematology testing should be within pre-specified ranges.

5. Subject is able to swallow capsules

6. Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

1. History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.

2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

3. Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.

4. Use of any of concomitant medication, including the drug listed below, that may interfere with the pharmacokinetics of LPV/r or SQV.

• NNRTIs

• Rifampicin

• Rifabutin

• Phenobarbital

• Phenytoine

• Carbamazepine

• Dexamethasone

• Ketoconazole

• Clarithromycin

5. Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Lopinavir/r plus saquinavir
lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily

Locations

Country	Name	City	State
Thailand	Chulalongkorn University Hospital, Department of Pediatrics	Bangkok
Thailand	The HIV Netherlands Australia Thailand Research Collaboration	Bangkok
Thailand	Khon Kaen University	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Roche for trial and Saquinavir,and Abbott for Kaletra

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Ananworanich J, Kosalaraksa P, Hill A, Siangphoe U, Bergshoeff A, Pancharoen C, Engchanil C, Ruxrungtham K, Burger D; HIV-NAT 017 Study Team. Pharmacokinetics and 24-week efficacy/safety of dual boosted saquinavir/lopinavir/ritonavir in nucleoside-pretrea — View Citation

Bunupuradah T, van der Lugt J, Kosalaraksa P, Engchanil C, Boonrak P, Puthanakit T, Mengthaisong T, Mahanontharit A, Lumbiganon P, Tompkins E, Burger D, Ruxrungtham K, Ananworanich J; HIV-NAT 017 Study Team. Safety and efficacy of a double-boosted proteas — View Citation

Jasper van der Lugt, Torsak Bunupuradah, Pope Kosalaraksa, Thanyawee Puthanakit, Chulapan Engchanil, Waraporn Sakornjun, Meena Gorowara, ROCHE, Kiat Ruxrungtham, David Burger, Jintanat Ananworanich: Therapeutic Drug Monitoring of lopinavir and saquinavir

Kosalaraksa P, Bunupuradah T, Engchanil C, Boonrak P, Intasan J, Lumbiganon P, Burger D, Ruxrungtham K, Schutz M, Ananworanich J; HIV-NAT 017 Study Team. Double boosted protease inhibitors, saquinavir, and lopinavir/ritonavir, in nucleoside pretreated chi — View Citation

Kosalaraksa P, Engchanil C, Bunupuradah T, Luesomboon W, Sunthornkachit R, Bunruen S, Intasan J, Jupimai T, Hirunwadee N, Lumbiganon P, Ruxrungtham K on behalf of the PREDICT study team. Prevalence of anemia and impact of iron status in Thai and Cambodian

Torsak Bunupuradah, Pope Kosalaraksa, Chulapan Engchanil, Pitch Boonrak, Tawan Hirunyanulux, Sasiwimol Ubolyam, Pagakrong Lumbiganon, Kiat Ruxrungtham, Emily Labriola-Tompkins, Jintanat Ananworanich, and HIV-NAT 017 Study Team: Efficacy and safety of doub

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months.		96 week	No

External Links

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