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: August 4, 2014
Last verified: August 2014

June 6, 2012
August 4, 2014
January 2012
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01638650 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: saquinavir [Invirase]
    500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14
  • Drug: ritonavir
    100 mg bid orally, Days 1-14
  • Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs)
    in accordance with current clinical HIV treatment guidelines
Experimental: Single Arm
Interventions:
  • Drug: saquinavir [Invirase]
  • Drug: ritonavir
  • Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01638650
NP25607
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP