Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
|HIV Infections||Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours||Phase 4|
|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.|
- Virological response: Viral Load [ Time Frame: weeks 24 and 48 ]
- 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 ]
|Study Start Date:||June 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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 .
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379405
|Germans Trias i Pujol University Hospital|
|Badalona, Barcelona, Spain, 08916|
|Hospital del Sant Pau.|
|Barcelona, Spain, 08025|
|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|