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Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy (DRV900100QD)
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00611039
First received: January 28, 2008
Last updated: October 5, 2009
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Darunavir 900mg + ritonavir 100 mg once a day Drug: Darunavir 600mg + ritonavir 100mg twice day | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- 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 Measures:
- DRV plasma trough concentration [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
- DRV Virtual inhibitory quotient (vIQ) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
- CD4 and CD8 lymphocytes count [ Time Frame: Screening, Basal, week 12, week 24, week 36 and week 48 ]
- 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 ]
- Karnofsky index [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48 ]
- Adverse events [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
- 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 ]
- 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 ]
- Genotype, if virological failure occurs [ Time Frame: When virological failure ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Darunavir 900mg + ritonavir 100 mg once a day
|
Drug: Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 900mg + ritonavir 100 mg once a day
|
|
Active Comparator: 2
Darunavir 600mg + ritonavir 100mg twice day
|
Drug: Darunavir 600mg + ritonavir 100mg twice day
Darunavir 600mg + ritonavir 100mg twice day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00611039
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611039
Locations
| Spain | |
| Germans Trias i Pujol Hospital | |
| Badalona, Barcelona, Spain, 08916 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
| Principal Investigator: | Bonaventura Clotet, MD,PhD | Fundacio Lluita Contra la SIDA |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | LLuita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT00611039 History of Changes |
| Other Study ID Numbers: |
DRV 900100 QD |
| Study First Received: | January 28, 2008 |
| Last Updated: | October 5, 2009 |
Keywords provided by Germans Trias i Pujol Hospital:
|
Darunavir/ritonavir virtual inhibitory quotient dose reduction |
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 Darunavir |
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 |
ClinicalTrials.gov processed this record on September 21, 2017