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:
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

January 28, 2008
October 5, 2009
February 2008
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Proportion of patients with HIV-1 viral load <50 copies /mL [ Time Frame: Basal, week 2, week 4, week 8, week 12 and week 24. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611039 on ClinicalTrials.gov Archive Site
  • DRV plasma trough concentration [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ] [ Designated as safety issue: Yes ]
  • DRV Virtual inhibitory quotient (vIQ) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ] [ Designated as safety issue: Yes ]
  • CD4 and CD8 lymphocytes count [ Time Frame: Screening, Basal, week 12, week 24, week 36 and week 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Karnofsky index [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Genotype, if virological failure occurs [ Time Frame: When virological failure ] [ Designated as safety issue: No ]
  • DRV plasma trough concentration [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • DRV Virtual inhibitory quotient (vIQ) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • CD4 and CD8 lymphocytes count [ Time Frame: Screening, Basal, week 12 and week 24 ] [ Designated as safety issue: No ]
  • Physical examination including weight and height [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • Karnofsky index [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • Treatment adherence (assesed by the phisician, but not recovered in the data base) [ Time Frame: Screening, Basal, week 2, week 4, week 8, week 12 and week 24 ] [ Designated as safety issue: Yes ]
  • Genotype, if virological failure occurs [ Time Frame: When virological failure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Darunavir 900mg + ritonavir 100 mg once a day
    Darunavir 900mg + ritonavir 100 mg once a day
  • Drug: Darunavir 600mg + ritonavir 100mg twice day
    Darunavir 600mg + ritonavir 100mg twice day
  • Experimental: 1
    Darunavir 900mg + ritonavir 100 mg once a day
    Intervention: Drug: Darunavir 900mg + ritonavir 100 mg once a day
  • Active Comparator: 2
    Darunavir 600mg + ritonavir 100mg twice day
    Intervention: Drug: Darunavir 600mg + ritonavir 100mg twice day
Moltó J, Valle M, Santos JR, Mothe B, Miranda C, Cedeño 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00611039
DRV 900100 QD
No
LLuita Sida Foundation
Germans Trias i Pujol Hospital
Not Provided
Principal Investigator: Bonaventura Clotet, MD,PhD Fundacio Lluita Contra la SIDA
Germans Trias i Pujol Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP