drugset / Trial / NCT00400738
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
Phase 2
Completed
48 enrolled
The HIV Netherlands Australia Thailand Research Collaboration
International Antiviral Therapy Evaluation Center · collabKirby Institute · collabRoche Pharma AG · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
Timeline
- Start
- 2004-03
- Primary completion
- 2006-12
- Completion
- 2006-12
Publications
- Background van der Lugt J, Autar RS, Ubolyam S, Garcia EF, Sankote J, Avihingsanon A, Chuenyam T, Cooper DA, Lange J, Phanuphak P, Wit F, Ruxrungtham K, Burger D; HIV-NAT 019 Study Team. Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults. J Antimicrob Chemother. 2008 May;61(5):1145-53. doi: 10.1093/jac/dkn050. Epub 2008 Feb 18.
- Maughan RT, Feeney ER, Capel E, Capeau J, Domingo P, Giralt M, Lange JM, Phanuphak P, Cooper DA, Reiss P, Mallon PW; HIVNAT-019 Study Group. Improved adipose tissue function with initiation of protease inhibitor-only ART. J Antimicrob Chemother. 2016 Nov;71(11):3212-3221. doi: 10.1093/jac/dkw301. Epub 2016 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir | Other / unclassified | 266 mg | — |
| Subject | Lopinavir | Other / unclassified | 400 mg | — |
| Subject | Ritonavir | Other / unclassified | 66 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | Saquinavir | Small molecule | 600 mg | — |
| Subject | Saquinavir | Small molecule | 1000 mg | — |