Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy (MonDar)
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ClinicalTrials.gov Identifier: NCT01606722 |
Recruitment Status
:
Completed
First Posted
: May 28, 2012
Last Update Posted
: July 11, 2013
|
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Condition or disease | Intervention/treatment |
---|---|
HIV-infection | Drug: Darunavir/ritonavir |
Study Type : | Observational |
Actual Enrollment : | 150 participants |
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 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- Virological efficacy [ Time Frame: 48 and 96 weeks ]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.
- Impact of viral breakthrough on DNA-HIV reservoirs and immunologic activation [ Time Frame: 48 and 96 weeks ]Impact of blips and persistent viraemia on DNA-HIV reservoirs and immunologic activation
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606722
Spain | |
Hospital Universitarios Virgen del Rocio | |
Seville, Spain, 41013 |
Study Chair: | Luis F Lopez-Cortes, MD, PhD. | Hospital Universitario Virgen del Rocio. Sevilla. Spain |
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 ( Other Grant/Funding Number: Consejeria de Salud. Junta de Andalucia (exp: PI-0448-2010) ) |
First Posted: | May 28, 2012 Key Record Dates |
Last Update Posted: | July 11, 2013 |
Last Verified: | July 2013 |
Keywords provided by Luis F. Lopez-Cortes, 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 Ritonavir Darunavir |
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 |