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OpenTrials
Completed

NCT Number: NCT01638650

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

London, SW10 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Drug

in accordance with current clinical HIV treatment guidelines

Ritonavir

Drug

100 mg bid orally, Days 1-14

saquinavir [Invirase]

Drug

500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14

Primary outcomes

  1. 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 outcomes

  1. Pharmacokinetics: Plasma concentrations

    Time frame: Pre-dose and 2, 4, 6, 8 and 12 hours post-dose, Days 3, 4, 7, 10 and 14

  2. Pharmacodynamics: Change in HIV-RNA levels

    Time frame: from baseline to Day 14

  3. Safety: Incidence of adverse events

    Time frame: approximately 6 months

  4. Change in ECG parameters

    Time frame: from baseline to Day 14

  5. Correlation between saquinavir plasma concentration and QTc interval changes

    Time frame: approximately 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 12, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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