A PK and Salvage Study for Children With HIV-infection
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ClinicalTrials.gov Identifier: NCT00476359 |
Recruitment Status
:
Completed
First Posted
: May 22, 2007
Last Update Posted
: March 27, 2015
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Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Roche for trial and Saquinavir,and Abbott for Kaletra
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
Tracking Information | |||||||
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First Submitted Date ICMJE | May 20, 2007 | ||||||
First Posted Date ICMJE | May 22, 2007 | ||||||
Last Update Posted Date | March 27, 2015 | ||||||
Study Start Date ICMJE | October 2003 | ||||||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00476359 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A PK and Salvage Study for Children With HIV-infection | ||||||
Official Title ICMJE | Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up | ||||||
Brief 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. | ||||||
Detailed 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | ||||||
Intervention ICMJE | Drug: Lopinavir/r plus saquinavir
lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily |
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Study Arms | double-boosted PI
double-boosted protease inhibitor combination
Intervention: Drug: Lopinavir/r plus saquinavir |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
50 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | November 2008 | ||||||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 16 Years (Child) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Thailand | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00476359 | ||||||
Other Study ID Numbers ICMJE | HIV-NAT 017 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | The HIV Netherlands Australia Thailand Research Collaboration | ||||||
Study Sponsor ICMJE | The HIV Netherlands Australia Thailand Research Collaboration | ||||||
Collaborators ICMJE | Roche for trial and Saquinavir,and Abbott for Kaletra | ||||||
Investigators ICMJE |
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PRS Account | The HIV Netherlands Australia Thailand Research Collaboration | ||||||
Verification Date | March 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |