A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents (DIONE)
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ClinicalTrials.gov Identifier: NCT00915655 |
Recruitment Status
:
Completed
First Posted
: June 8, 2009
Results First Posted
: December 28, 2011
Last Update Posted
: September 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Infection | Drug: darunavir Drug: ritonavir Drug: zidovudine Drug: lamivudine Drug: abacavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: DRV/rtv (darunavir/ritonavir)
Patients will receive darunavir tablets 2 x 400 mg in combination with ritonavir capsule 100 mg once daily for 48 weeks along with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) ie, either zidovudine/lamivudine or abacavir/lamivudine
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Drug: darunavir
Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks
Other Name: DRV
Drug: ritonavir
Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks
Other Name: rtv
Drug: zidovudine
NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
Drug: lamivudine
NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
Drug: abacavir
NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and < 18 years in a particular country
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- Virological Response[Viral Load <50 Copies/mL, TLOVR] [ Time Frame: Week 24 ]The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.
- Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT] [ Time Frame: Week 24 ]The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).

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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a documented HIV-1 infection
- Body weight from at least 40 kg at screening
- Screening plasma HIV-1 RNA >= 1000 copies/mL
- Parents or legal representative and trial patients (where appropriate, depending on age and local regulation) willing and able to give consent and assent
- General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial
- Able to swallow darunavir tablets (400 mg) and ritonavir capsules (100 mg)
Exclusion Criteria:
- Patients with presence of any currently active conditions included in the listing of World Health Organisation (WHO) Clinical Stage 4
- Any condition (including, but not limited to, alcohol and drug use), which, in the opinion of the investigator, could compromise the patient's safety or adherence to the trial protocol
- Previous or current use of antiretrovirals (ARVs)
- Primary or acute HIV infection
- Use of any investigational agents within 30 days prior to screening
- Use of disallowed concomitant therapy
- Pregnant or breast-feeding
- Female patient of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
- Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation (ie, liver insufficiency), irrespective of liver enzyme levels
- Any active clinically significant disease (eg, cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial

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): NCT00915655
United States, Tennessee | |
Memphis, Tennessee, United States | |
France | |
Paris, France | |
Ireland | |
Dublin, Ireland | |
Spain | |
Esplugues De Llobregat, Spain | |
Madrid, Spain | |
Ukraine | |
Kiev, Ukraine | |
United Kingdom | |
Birmingham, United Kingdom | |
Bristol, United Kingdom | |
Stoke On Trent, United Kingdom |
Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
Responsible Party: | Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT00915655 History of Changes |
Other Study ID Numbers: |
CR016312 TMC114-TiDP29-C230 ( Other Identifier: Tibotec Pharmaceuticals, Ireland ) 2008-004631-37 ( EudraCT Number ) |
First Posted: | June 8, 2009 Key Record Dates |
Results First Posted: | December 28, 2011 |
Last Update Posted: | September 3, 2012 |
Last Verified: | August 2012 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV Infections TMC114-TiDP29-C230 TMC114-C230 TMC114 HIV-1 |
Darunavir Ritonavir NRTI Treatment Naive |
Additional relevant MeSH terms:
Ritonavir Darunavir Lamivudine Zidovudine Abacavir Antiviral Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites |