A PK and Salvage Study for Children With HIV-infection
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Roche for trial and Saquinavir,and Abbott for Kaletra
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476359
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/r plus saquinavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months. [ Time Frame: 96 week ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | October 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Lopinavir/r plus saquinavir
lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
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.
Eligibility| Ages Eligible for Study: | 1 Year to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- Subject is less than or equal to 16 years of age at the day of the first dosing.
- Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.
- Results of biochemistry and haematology testing should be within pre-specified ranges.
- Subject is able to swallow capsules
- Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.
Exclusion Criteria:
- History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.
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
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476359
Locations
| Thailand | |
| The HIV Netherlands Australia Thailand Research Collaboration | |
| Bangkok, Thailand, 10330 | |
| Chulalongkorn University Hospital, Department of Pediatrics | |
| Bangkok, Thailand, 10330 | |
| Khon Kaen University | |
| Khon Kaen, Thailand, 40002 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Roche for trial and Saquinavir,and Abbott for Kaletra
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT, Bangkok, Thailand |
| Principal Investigator: | Pope Kosalaraksa, MD | Khon Kaen University |
More Information
Additional Information:
Publications:
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 HIV infected children with moderate immunosuppression (PREDICT study), poster No. TUPEB 137. Poster presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, July 22-25, 2007
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 in Thai HIV infected Children. Poster will be presented at the 15th Conference on Retroviruses and Opportunistic Infections, Boston, USA, February 3-7, 2008.
| Responsible Party: | The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand |
| ClinicalTrials.gov Identifier: | NCT00476359 History of Changes |
| Other Study ID Numbers: | HIV-NAT 017 |
| Study First Received: | May 20, 2007 |
| Last Updated: | June 4, 2010 |
| Health Authority: | Thailand: Ethical Committee Thailand: Khon Kaen University Ethics Committee for Human Research |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
Lopinavir/r Saquinavir Dual boosted PIs Pharmacokinetics HIV children C min |
Second line HAART ARV VL failure Dosage To evaluate treatment response Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Saquinavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013