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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Darunavir 600mg + ritonavir 100mg twice day; Drug: Darunavir 900mg + ritonavir 100 mg once a day

• Registration Number: NCT00611039
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

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 Timeline

• Study First Submitted: 2008-01-28
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Darunavir 600mg + ritonavir 100mg twice day	Darunavir 600mg + ritonavir 100mg twice day
1	Darunavir 900mg + ritonavir 100 mg once a day	Darunavir 900mg + ritonavir 100 mg once a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Karnofsky index	Screening, Basal, week 2, week 4, week 8, week 12, week 24, week, 36 and week 48
DRV plasma trough concentration	Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Adverse events	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)	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)	Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
DRV Virtual inhibitory quotient (vIQ)	Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
CD4 and CD8 lymphocytes count	Screening, Basal, week 12, week 24, week 36 and week 48
Physical examination including weight and height	Screening, Basal, week 2, week 4, week 8, week 12, week 24, week 36 and week 48
Genotype, if virological failure occurs	When virological failure

Trial Locations

Locations (1)

Germans Trias i Pujol Hospital; 🇪🇸 Badalona, Barcelona, Spain