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Completed

NCT Number: NCT00611039

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darunavir 900mg + ritonavir 100 mg once a day

Drug

Darunavir 900mg + ritonavir 100 mg once a day

Darunavir 600mg + ritonavir 100mg twice day

Drug

Darunavir 600mg + ritonavir 100mg twice day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Collaborators

  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Registry information

Official study 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

Acronym: DRV900100QD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2008
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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