Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
Information source: Germans Trias i Pujol Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Germans Trias i Pujol Hospital Official(s) and/or principal investigator(s):
Clotet Bonaventura, MD,PhD, Principal Investigator, Affiliation: Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)
Negredo Eugenia, MD,PhD, Principal Investigator, Affiliation: Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Echeverria Patricia, MD,PhD, Principal Investigator, Affiliation: Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Molto Jose, MD,PhD, Principal Investigator, Affiliation: Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Pere Domingo, MD, PhD, Principal Investigator, Affiliation: Hospital de Sant Pau
Summary
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance
therapy, compared to standard HAART therapies.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Virological response: Viral Load
Secondary outcome: CD4 and CD8 lymphocyte count.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,... Karnofsky Index. Adverse events. Trough plasma concentrations of Saquinavir. Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) Serology for Hepatitis B and C virus. Assessment of treatment adherence. Assessment of quality of life (by means of the MOS-HIV questionnaire). Genotype if virological failure.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Hospital del Sant Pau., Barcelona 08025, Spain
Germans Trias i Pujol University Hospital, Badalona, Barcelona 08916, Spain
Additional Information
Starting date: June 2006
Ending date: May 2008
Last updated: January 25, 2008
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