deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT00476359

A PK and Salvage Study for Children With HIV-infection

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

Sponsor: Roche for trial and Saquinavir,and Abbott for Kaletra

Conditions HIV Infections
Interventions Lopinavir/r plus saquinavir
Updated 5 times since 2017 Last updated: Mar 26, 2015 Started: Oct 31, 2003 Primary completion: Nov 30, 2008 Completion: Nov 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on HIV Infections, this trial is completed. The trial is conducted by Roche for trial and Saquinavir,and Abbott for Kaletra and has accumulated 5 data snapshots since 2003. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Oct 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Roche for trial and Saquinavir,and Abbott for Kaletra
  • The HIV Netherlands Australia Thailand Research Collaboration
Data source: The HIV Netherlands Australia Thailand Research Collaboration

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations