Back to resultsEvaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy (DRV900100QD)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 600mg + ritonavir 100mg twice day
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Darunavir/ritonavir, virtual inhibitory quotient, dose reduction
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years.
- HIV-infected patients.
- Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
- HIV viral load < 50 copies/mL for at least 12 weeks.
- Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
- Darunavir vIQ >= 2.
- Subject able to follow the treatment period.
- In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
- Signature of the informed consent.
Exclusion Criteria:
- AIDS-defining illness in the last 4 weeks.
- Suspicion of unsuitable antiretroviral treatment compliance.
- In women, pregnancy or breastfeeding.
- Record or suspicion of incapability to cooperate as appropriate.
Sites / Locations
- Germans Trias i Pujol Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 600mg + ritonavir 100mg twice day
Outcomes
Primary Outcome Measures
Proportion of patients with HIV-1 viral load < 50 copies /mL
Secondary Outcome Measures
DRV plasma trough concentration
DRV Virtual inhibitory quotient (vIQ)
CD4 and CD8 lymphocytes count
Physical examination including weight and height
Karnofsky index
Adverse events
Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)
Treatment adherence (assessed by the physician, but not recovered in the data base)
Genotype, if virological failure occurs
Full Information
NCT ID
NCT00611039
First Posted
January 28, 2008
Last Updated
December 3, 2019
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
1. Study Identification
Unique Protocol Identification Number
NCT00611039
Brief Title
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
Acronym
DRV900100QD
Official Title
Clinical Pilot, Open, Comparative and Randomized Trial to Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
Detailed Description
The probability of achieving viral replication suppression during the treatment with DRV has been related to both the extent of viral resistance to DRV (inhibitory concentration 50%, IC50) and the drug concentration. Moreover, the DRV virtual inhibitory quotient (vIQ) has been related significantly with the virological response to DRV treatment. So patients with a DRV vIQ >= 1,5 had a 8-times higher probability of having viral load < 50 copies/mL after 24 weeks of treatment than those having a vIQ < 1,5.
Considering the previous arguments, it is possible to think in the possibility of simplifying the rescue treatment with DRV/ritonavir to 900/100 mg once a day in those patients who are being treated with DRV/ritonavir 600/100 mg twice a day and who, besides having undetectable viral load, have a DRV vIQ over 2. This strategy would not jeopardize the efficacy of the antiretroviral treatment and would have less impact in the lipid profile of the patients as well as less pharmaceutical expenditure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Darunavir/ritonavir, virtual inhibitory quotient, dose reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Darunavir 900mg + ritonavir 100 mg once a day
Arm Title
2
Arm Type
Active Comparator
Arm Description
Darunavir 600mg + ritonavir 100mg twice day
Intervention Type
Drug
Intervention Name(s)
Darunavir 900mg + ritonavir 100 mg once a day
Intervention Description
Darunavir 900mg + ritonavir 100 mg once a day
Intervention Type
Drug
Intervention Name(s)
Darunavir 600mg + ritonavir 100mg twice day
Intervention Description
Darunavir 600mg + ritonavir 100mg twice day
Primary Outcome Measure Information:
Title
Proportion of patients with HIV-1 viral load < 50 copies /mL
Time Frame
Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48
Secondary Outcome Measure Information:
Title
DRV plasma trough concentration
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
DRV Virtual inhibitory quotient (vIQ)
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
CD4 and CD8 lymphocytes count
Time Frame
Screening, Basal, week 12, week 24, week 36 and week 48
Title
Physical examination including weight and height
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
Karnofsky index
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Title
Adverse events
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
Treatment adherence (assessed by the physician, but not recovered in the data base)
Time Frame
Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Title
Genotype, if virological failure occurs
Time Frame
When virological failure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years.
HIV-infected patients.
Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
HIV viral load < 50 copies/mL for at least 12 weeks.
Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
Darunavir vIQ >= 2.
Subject able to follow the treatment period.
In women, negative pregnancy test or not in fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or undertaking to use a barrier contraceptive method during the study.
Signature of the informed consent.
Exclusion Criteria:
AIDS-defining illness in the last 4 weeks.
Suspicion of unsuitable antiretroviral treatment compliance.
In women, pregnancy or breastfeeding.
Record or suspicion of incapability to cooperate as appropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD,PhD
Organizational Affiliation
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20386077
Citation
Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.
Results Reference
derived
Learn more about this trial
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
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