Phase 2
Completed N=21
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
Human Immunodeficiency Virus 1
Source: ClinicalTrials.gov NCT00919854 ↗
Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Jun 2013
Primary outcomePrimary: Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR) — 13 Participants
Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR) |
13 | — |
| SECONDARY Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48 |
17 | — |
| SECONDARY Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48 |
17; 18 | — |
| SECONDARY Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48 |
17; 19 | — |
| SECONDARY Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load |
-2.04; -2.14 | — |
| SECONDARY Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage |
4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.)
- Body weight from 10 kg to less than 20 kg at screening
- Participants currently on stable ART (anti retroviral therapy) for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of greater than 1000 copies/mL
- Screening genotype resistance test results showing less than 3 DRV resistance-associated mutations
- Parents or legal representative willing and able to give consent
Exclusion Criteria
- Participants with presence of any currently active conditions included in the listing of WHO ( World Health Organisation) Clinical Stage 4 and participants with presence of a non-HIV encephalopathy
- Administration of any ARV (antiretroviral) or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available
- Life expectancy less than 6 months, according to the judgment of the investigator
- Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor
- Participants with any active clinically significant disease (eg, tuberculosis [TB], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the subject's safety or outcome of the study
Data sourced from ClinicalTrials.gov (NCT00919854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.