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: May 7, 2013
Last verified: May 2013
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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: saquinavir [Invirase] Drug: ritonavir Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTIs) |
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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
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
|
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 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: | May 7, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Reverse Transcriptase Inhibitors Saquinavir |
Ritonavir Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013