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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)

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ClinicalTrials.gov Identifier: NCT00611039
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Darunavir 900mg + ritonavir 100 mg once a day Drug: Darunavir 600mg + ritonavir 100mg twice day Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. DRV plasma trough concentration [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
  2. DRV Virtual inhibitory quotient (vIQ) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
  3. CD4 and CD8 lymphocytes count [ Time Frame: Screening, Basal, week 12, week 24, week 36 and week 48 ]
  4. 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 ]
  5. Karnofsky index [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48 ]
  6. Adverse events [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ]
  7. 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 ]
  8. 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 ]
  9. Genotype, if virological failure occurs [ Time Frame: When virological failure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years.
  2. HIV-infected patients.
  3. Stable antiretroviral treatment including darunavir/ritonavir 600/100 every 12 hours for at least 4 weeks.
  4. HIV viral load < 50 copies/mL for at least 12 weeks.
  5. Resistance test (Genotype or Virtual Phenotype) before starting tipranavir treatment.
  6. Darunavir vIQ >= 2.
  7. Subject able to follow the treatment period.
  8. 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.
  9. Signature of the informed consent.

Exclusion Criteria:

  1. AIDS-defining illness in the last 4 weeks.
  2. Suspicion of unsuitable antiretroviral treatment compliance.
  3. In women, pregnancy or breastfeeding.
  4. Record or suspicion of incapability to cooperate as appropriate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 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