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Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379405
First Posted: September 21, 2006
Last Update Posted: October 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundacio Lluita Contra la SIDA
Information provided by:
Germans Trias i Pujol Hospital
  Purpose
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

Condition Intervention Phase
HIV Infections Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • Virological response: Viral Load [ Time Frame: weeks 24 and 48 ]

Secondary Outcome Measures:
  • CD4 and CD8 lymphocyte count. [ Time Frame: weeks 24 and 48 ]
  • Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,... [ Time Frame: weeks 24 and 48 ]
  • Karnofsky Index. [ Time Frame: weeks 24 and 48 ]
  • Adverse events. [ Time Frame: during the 48 weeks of follow-up ]
  • Trough plasma concentrations of Saquinavir. [ Time Frame: during the 48 weeks of follow-up ]
  • Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) [ Time Frame: during the 48 weeks of follow-up ]
  • Serology for Hepatitis B and C virus. [ Time Frame: at baseline visit ]
  • Assessment of treatment adherence. [ Time Frame: at baseline and weeks 4, 12, 24, 36 and 48 ]
  • Assessment of quality of life (by means of the MOS-HIV questionnaire). [ Time Frame: at baseline and weeks 4, 12, 24, 36 and 48 ]
  • Genotype if virological failure. [ Time Frame: at any time of study if it is necessary ]

Enrollment: 30
Study Start Date: June 2006
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Saquinavir (Invirase): 2 capsules (500 mg) / 12 hours
Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
Other Name: Invirase
No Intervention: 2
IP o NNUCS + 2 NUCS as a HAART therapy .

Detailed Description:

Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity. Both the reduction in the number of doses and the number of daily tablets have led to an improvement in therapeutic compliance. Similarly, the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single therapy with PIs boosted with ritonavir.

In this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir.

There are other PIs whose antiretroviral efficacy has also been demonstrated, such as saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity profile, and the availability of saquinavir 500 mg facilitates comfortable administration, since it makes it possible to reduce the number of daily tablets to more than half.

Moreover, it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low, which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics (high intrinsic potency, low number of tablets, low toxicity, low potential of selection of resistant viral strains in combination with ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir, boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients infected by HIV-1 (at least one documented positive Western-Blot).
  • Age > 18 years.
  • Patients on antiretroviral treatment (standard HAART therapy) for at least six months.
  • HIV-1 plasma viral load <50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).
  • Patients without evidence of previous virological failure to IP
  • Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
  • Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.
  • Signature of the informed consent.

Exclusion Criteria:

  • Suspicion of unsuitable antiretroviral treatment compliance.
  • Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.
  • Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  • Hepatic tests (AST, ALT, GGT) > or equal to 5 times the upper limit of normality during the three months prior to the screening visit
  • Presence of renal impairment (creatinine > or equal to 1.5 times the upper limit of normality).
  • Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.
  • Participation in another clinical trial wich entail the antiretroviral treatment modification.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379405


Locations
Spain
Germans Trias i Pujol University Hospital
Badalona, Barcelona, Spain, 08916
Hospital del Sant Pau.
Barcelona, Spain, 08025
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fundacio Lluita Contra la SIDA
Investigators
Principal Investigator: Clotet Bonaventura, MD,PhD Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)
Principal Investigator: Negredo Eugenia, MD,PhD Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Principal Investigator: Echeverria Patricia, MD,PhD Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Principal Investigator: Molto Jose, MD,PhD Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Principal Investigator: Pere Domingo, MD, PhD Hospital de Sant Pau
  More Information

Responsible Party: Lluita Sida Foundation
ClinicalTrials.gov Identifier: NCT00379405     History of Changes
Other Study ID Numbers: SQV/RTV-MONOTERAPIA
2006-001136-47
First Submitted: September 20, 2006
First Posted: September 21, 2006
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by Germans Trias i Pujol Hospital:
Saquinavir/ritonavir
Single therapy
Virological efficacy
Safety
HIV-1

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Saquinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors