Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
Hoffmann-La Roche
ClinicalTrials.gov Identifier
NCT01638650

First received: June 6, 2012
Last updated: November 1, 2016
Last Verified: November 2016
History of Changes
Purpose

Purpose

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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


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 1, 2016  

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Saquinavir
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.