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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01638650
First received: June 6, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open-label study will evaluate the safety, pharmacokinetics and antiviral a ctivity of a modified Invirase (saquinavir)/ritonavir regimen in treatment-naïve HIV-1 infected patients. Patients will receive Invirase 500 mg plus ritonavir 1 00 mg twice daily orally for the first week, followed by Invirase 1000 mg plus r itonavir 100 mg twice daily orally for the second week. The study treatment will be given in combination with two Nucleoside Reverse Transcriptase Inhibitors (N RTIs), in accordance with the current clinical HIV treatment guidelines. Anticip ated 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: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Change in HIV-RNA levels [ Time Frame: from baseline to Day 14 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
  • Change in ECG parameters [ Time Frame: from baseline to Day 14 ] [ Designated as safety issue: No ]
  • Correlation between saquinavir plasma concentration and QTc interval changes [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638650

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01638650     History of Changes
Other Study ID Numbers: NP25607
Study First Received: June 6, 2012
Last Updated: November 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Ritonavir
Saquinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014