Trial Outcomes & Findings for A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents (NCT NCT00915655)
NCT ID: NCT00915655
Last Updated: 2012-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Week 24
Results posted on
2012-09-03
Participant Flow
Participant milestones
| Measure |
DRV/Rtv
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
Baseline characteristics by cohort
| Measure |
DRV/Rtv
n=12 Participants
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Age Continuous
|
14.7 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Percentile for Height
|
27.2 Height Percentile
n=5 Participants
|
|
Percentile for BMI
|
47.5 BMI Percentile
n=5 Participants
|
|
Percentile for Weight
|
51.6 Weight Percentile
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The ITT analysis set was considered the primary efficacy analysis set.
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.
Outcome measures
| Measure |
DRV/Rtv
n=12 Participants
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Virological Response[Viral Load <50 Copies/mL, TLOVR]
Yes
|
11 Participants
|
|
Virological Response[Viral Load <50 Copies/mL, TLOVR]
No
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: The ITT analysis set was considered the primary efficacy analysis set.
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).
Outcome measures
| Measure |
DRV/Rtv
n=12 Participants
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]
|
12 Participants
|
Adverse Events
DRV/Rtv
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DRV/Rtv
n=12 participants at risk
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
Other adverse events
| Measure |
DRV/Rtv
n=12 participants at risk
Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
|
|---|---|
|
Infections and infestations
Furuncle
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Sinusitis
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Herpes simplex
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Herpes zoster
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Otitis media acute
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Eye disorders
Conjunctival hyperaemia
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Eye disorders
Conjunctivitis allergic
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Eye disorders
Keratitis
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
General disorders
Pyrexia
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Nail injury
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12
Only patients who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. patients with Non-Serious Adverse Events.
|
Additional Information
Medical Leader
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: +1 609 730-7548
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will not unreasonably withhold consent to publish the data generated in this trial. However, it is the policy of the Sponsor not to allow the investigators to publish their results or findings prior to the Sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher.
- Publication restrictions are in place
Restriction type: OTHER