The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients

NCT00400738 | Completed Phase 2

• 1 other identifier: HIV-NAT 019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV-1 infection; pharmacokinetics; protease inhibitor; double boosted protease inhibitors; PIs; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients

  1 year

Secondary Outcomes (1)

• To describe short-term tolerability, toxicity and efficacy of combinations of low-dose and standard dose lopinavir/ritonavir and saquinavirHGC given to the patients in this trial

  1 year

Study Arms (4)

1

EXPERIMENTAL

different dose per arm

Drug: Saquinavir, lopinavir, ritonavir

2

EXPERIMENTAL

different dose per arm

Drug: Saquinavir, lopinavir, ritonavir

3

EXPERIMENTAL

different dose per arm

Drug: Saquinavir, lopinavir, ritonavir

4

EXPERIMENTAL

different dose per arm

Drug: Saquinavir, lopinavir, ritonavir

Interventions

Saquinavir, lopinavir, ritonavir DRUG

arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• ARV-naïve
• HIV-1 infected Thai male or female \> 18 years old
• Documented positive test for HIV-1 infection

You may not qualify if:

• Inability to understand the nature and extent of the study and the procedures required.
• Pregnancy or lactating
• Active opportunistic infection
• ALT/ AST more than 2x upper limit
• creatinine more than 1.5 time the upper limit
• Smoke cigarettes more than 10 cigarettes a day.
• Drink alcohol more than 2 units a day
• Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
• Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Roche Pharma AG: collaborator
• International Antiviral Therapy Evaluation Center: collaborator
• Kirby Institute: collaborator

Study Sites (1)

The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, 10330, Thailand

Location

Related Publications (2)

• 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.

  PMID: 18285316 BACKGROUND

• 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.

  PMID: 27516476 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Saquinavir; Lopinavir; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinolines; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Kiat Ruxrunghtam, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

• Joep Lange, MD, PhD

  International Antiviral Therapy Evaluation Center (IATEC), Center for Poverty-related Communicable Diseases, Department of Internal Medicine, Academic Medical Center (AMC), University of Amsterdam (UVA)

  STUDY CHAIR

• Praphan Phanuphak, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  STUDY CHAIR

• David Burger, PharmD, PhD

  Radboud University Medical Center

  STUDY CHAIR

• David Cooper, MD, PhD

  National Center in HIV Epidemiology and Clinical Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 17, 2006
• Study Start: March 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

TH (1)