Evaluate the Efficacy and Security of Darunavir/Ritonavir 900/100 mg Once a Day as an Antiretroviral Treatment Simplification Strategy

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611039
• Other study ID #: DRV 900100 QD
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2019
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Darunavir 900mg + ritonavir 100 mg once a day
Darunavir 900mg + ritonavir 100 mg once a day
• Darunavir 600mg + ritonavir 100mg twice day
Darunavir 600mg + ritonavir 100mg twice day

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HIV-1 viral load < 50 copies /mL		Basal, week 2, week 4, week 8, week 12 ,week 24week 36 and week 48
Secondary	DRV plasma trough concentration		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	DRV Virtual inhibitory quotient (vIQ)		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	CD4 and CD8 lymphocytes count		Screening, Basal, week 12, week 24, week 36 and week 48
Secondary	Physical examination including weight and height		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	Karnofsky index		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
Secondary	Adverse events		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	Lipid profile (total cholesterol, HDL-cholesterol. LDL-cholesterol and triglycerides)		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	Treatment adherence (assessed by the physician, but not recovered in the data base)		Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Secondary	Genotype, if virological failure occurs		When virological failure