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A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 6, 2012
Last updated: November 1, 2016
Last verified: November 2016
This open-label study will evaluate the safety, pharmacokinetics and antiviral activity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 100 mg twice daily orally for the first week, followed by Invirase 1000 mg plus ritonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines. Anticipated time on study treatment is 14 days.

Condition Intervention Phase
HIV Infections Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs) Drug: ritonavir Drug: saquinavir [Invirase] Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Determine the Effect of the Modified SQV/r (Saquinavir-boosted by Ritonavir) Regimen (500/100 mg for the 1st Week Followed by 1000/100 mg for the 2nd Week) on the QTc Interval, Pharmacokinetics, and Antiviral Activity in Treatment-naive HIV-1 Infected Patients

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Maximal increase in QTc interval (continuous Holter 12-lead ECG monitoring time points Days 1, 3, 4, 7, 10 and 14) [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations [ Time Frame: Pre-dose and 2, 4, 6, 8 and 12 hours post-dose, Days 3, 4, 7, 10 and 14 ]
  • Pharmacodynamics: Change in HIV-RNA levels [ Time Frame: from baseline to Day 14 ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6 months ]
  • Change in ECG parameters [ Time Frame: from baseline to Day 14 ]
  • Correlation between saquinavir plasma concentration and QTc interval changes [ Time Frame: approximately 6 months ]

Enrollment: 23
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs)
in accordance with current clinical HIV treatment guidelines
Drug: ritonavir
100 mg bid orally, Days 1-14
Drug: saquinavir [Invirase]
500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HIV-1 infection
  • Currently treatment-naïve and eligible to initiate a ritonavir-boosted Protease Inhibitor based regimen and willing and able to initiate saquinavir/ritonavir therapy for the first 14 days; the saquinavir/ritonavir regimen will be in combination with two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), in accordance with the current clinical HIV treatment guidelines
  • Body mass index 18-32 kg/m2, inclusive
  • Female patients of childbearing potential and male patients with female partners of childbearing potential must use 2 methods of contraception as defined by protocol during the study and for at least one month after the last dose of study drug
  • Non-smoker or patients who have stopped smoking more than three months prior to Day 1 of the study

Exclusion Criteria:

  • Coinfection with hepatitis B or C (acute or chronic)
  • Anticipated use or need for significant concomitant medical treatment during the study period, other than background antiretroviral therapy
  • Participation in a clinical study with an investigational drug or device within 3 months prior to Day 1 of the study
  • Pregnant or lactating women
  • Any clinically relevant history of substance abuse or addiction including alcohol and/or other drugs of abuse
  • Special dietary restrictions that would prohibit consumption of standardized meal (e.g. vegetarian, vegan, gluten-free, lactose-free, kosher)
  • Decompensated liver disease
  • Congenital or documented acquired QT prolongation
  • Electrolyte disturbances, particularly uncorrected hypokalaemia
  • Clinically relevant bradycardia
  • Clinically relevant heart failure with reduced left-ventricular ejection fraction
  • Previous history of symptomatic arrhythmias
  • History of clinically significant gastro-intestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, , hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01638650

United Kingdom
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01638650     History of Changes
Other Study ID Numbers: NP25607
Study First Received: June 6, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017