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.
Sponsor study identifier
Secondary identifiers
interventional
30
1 country
2
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2006
Actual (reported)September 21, 2006
Actual (reported)May 2008
Actual (reported)July 2008
Actual (reported)Virological response: Viral Load
weeks 24 and 48
CD4 and CD8 lymphocyte count.
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,...
weeks 24 and 48
Karnofsky Index.
weeks 24 and 48
Adverse events.
during the 48 weeks of follow-up
Trough plasma concentrations of Saquinavir.
during the 48 weeks of follow-up
Saquinavir (Invirase): 2 capsules (500 mg) / 12 hours
IP o NNUCS + 2 NUCS as a HAART therapy .
Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGermans Trias i Pujol University Hospital
Badalona, Barcelona, 08916, Spain
Hospital del Sant Pau.
Barcelona, 08025, Spain
Clotet Bonaventura, MD,PhD
Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)
Negredo Eugenia, MD,PhD
Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Echeverria Patricia, MD,PhD
Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
Molto Jose, MD,PhD
Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)
30 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2006
First Posted
September 21, 2006
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Pere Domingo, MD, PhD
Hospital de Sant Pau
Primary Completion
May 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
December 4, 2019
Record last verified: 2019-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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