Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy (MonDar)
This study has been completed.
Sponsor:
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier:
NCT01606722
First received: May 24, 2012
Last updated: July 10, 2013
Last verified: July 2013
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Purpose
To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
| Condition | Intervention |
|---|---|
|
HIV-infection |
Drug: Darunavir/ritonavir |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Relation Between Darunavir Levels and Virological Efficacy, Integrated Proviral ADN and Resistance Mutations in HIV-infected Patients on Treatment With Darunavir/Ritonavir Monotherapy |
Resource links provided by NLM:
Further study details as provided by Hospitales Universitarios Virgen del Rocío:
Primary Outcome Measures:
- Virological efficacy [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]To correlate the plasma and intracellular (cell-associated)) DRV levels with the virological efficacy analyzed by the time to loss of virological response (TLOVR) algorithm, considering VF as either: 1) two consecutive viral load >200 copies/mL, 2) a unique HIV-RNA >200 copies/mL if followed by lost to follow-up, or 3) the reintroduction of nucleos(t)ides because any reason.
Secondary Outcome Measures:
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation
Biospecimen Retention: Samples Without DNA
Blood samples (plasma and PBMC)
| Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Darunavir-ritonavir monotherapy
HIV-infected patients with undetectable viral load for at least for 6 months on stable therapy and no darunavir related mutations in the HIV-protease gene
|
Drug: Darunavir/ritonavir
Darunavir/ritonavir (800/100 mg once daily) monotherapy
Other Name: Prezista/norvir
|
Detailed Description:
To be enrolled, subjects had a plasma HIV-RNA <50 copies/mL for at least 6 months based, virologic failure while on a PI-containing regimen was allowed if the genotypic resistance tests showed no major resistance mutation associated to reduced susceptibility to DRV/rtv according to the International AIDS Society. Patients with transitory episodes of detectable plasma HIV-RNA viral load ("blip") preceded and followed by a plasma viral load <50 copies/mL without changes in antiretroviral treatment could also been included. The only exclusion criteria were pregnancy, hepatitis B coinfection and the concomitant use of drugs with potential major interactions with DRV/rtv pharmacokinetics.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected patients who started an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010
Criteria
Inclusion Criteria:
- Older than 18 years, starting an antiretroviral regimen based on darunavir-ritonavir (800/100 mg) once daily monotherapy between June 2010 and September 2010
- Plasma RNA-VIH < 50 copies/ml on stable antiretroviral treatment for ≥ 6 months
- Absence of resistance mutations in the protease gene, based on treatment history and/or genotypic resistance testing. that would decrease darunavir susceptibility
Exclusion Criteria:
- Pregnancy
- Chronic B hepatitis
- Genotypic resistance tests with evidence of resistance mutations in the protease gene that would decrease darunavir susceptibility
- Concomitant use of drugs with potentially adverse interactions with darunavir-ritonavir pharmacokinetics, such as rifampin
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01606722
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606722
Locations
| Spain | |
| Hospital Universitarios Virgen del Rocio | |
| Seville, Spain, 41013 | |
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Investigators
| Study Chair: | Luis F Lopez-Cortes, MD, PhD. | Hospital Universitario Virgen del Rocio. Sevilla. Spain |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Luis F. Lopez-Cortes, MD, PhD., Hospitales Universitarios Virgen del Rocío |
| ClinicalTrials.gov Identifier: | NCT01606722 History of Changes |
| Other Study ID Numbers: | LLC-DAR-2010-01 LLC-DAR-2010-01 |
| Study First Received: | May 24, 2012 |
| Last Updated: | July 10, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospitales Universitarios Virgen del Rocío:
|
Antiretroviral therapy Boosted-Darunavir monotherapy Resistance Proviral DNA-HIV |
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 Darunavir Ritonavir |
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 |
ClinicalTrials.gov processed this record on September 30, 2016