Trial Outcomes & Findings for TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV (NCT NCT01281813)
NCT ID: NCT01281813
Last Updated: 2022-10-31
Results Overview
Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
Up to 9 years 11 months
Results posted on
2022-10-31
Participant Flow
Participants who had completed treatment with darunavir/ritonavir (DRV/rtv) in the adult clinical (parent) trials TMC114-C211 (NCT00258557), TMC114-C214 (NCT00110877), TMC114-TiDP31-C229 (NCT00524368) or in the pediatric (parent) trial TMC114-TiDP29-C232 (NCT01138605), who continued to benefit from the use of DRV/rtv, and who lived in a country where DRV was not accessible participated in this trial and continued treatment as per their respective parent study.
Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies (TMC114-C211,TMC114-C214 or TMC114-TiDP31-C229). Main purpose of this study was to provide continued access and not to compare the 2 doses (DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily).
Participant milestones
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
137
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
137
|
Reasons for withdrawal
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
10
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
31
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
13
|
|
Overall Study
Subject Non-Compliant
|
0
|
0
|
6
|
|
Overall Study
Subject Reached A Virologic Endpoint
|
0
|
0
|
5
|
|
Overall Study
Sponsor's Decision
|
4
|
3
|
7
|
|
Overall Study
Switched to Commercially Available Medication
|
0
|
0
|
26
|
|
Overall Study
Other
|
0
|
1
|
39
|
Baseline Characteristics
TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV
Baseline characteristics by cohort
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 Participants
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 Participants
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 Participants
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11 years
STANDARD_DEVIATION 0 • n=5 Participants
|
13.8 years
STANDARD_DEVIATION 2.87 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
BRAZIL
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
COSTA RICA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
GUATEMALA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
MALAYSIA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
PANAMA
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Region of Enrollment
THAILAND
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
UKRAINE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 years 11 monthsPopulation: Full Analysis Set (FAS) included all participants who had taken at least one dose of Darunavir (DRV), regardless of their compliance with the protocol and adherence to the dose regimen.
Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Outcome measures
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 Participants
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 Participants
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 Participants
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
0 Participants
|
1 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Up to 9 years 11 monthsPopulation: FAS included all participants who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease) that occurred in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Outcome measures
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 Participants
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 Participants
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 Participants
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
|
0 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Up to 9 years 11 monthsPopulation: FAS included all participants who had taken at least one dose of DRV, regardless of their compliance with the protocol and adherence to the dose regimen.
Number of participants with adverse events possibly related to DRV/rtv treatment were reported. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Outcome measures
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 Participants
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 Participants
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 Participants
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Number of Participants With Adverse Events Possibly Related to Darunavir/Ritonavir (DRV/Rtv) Treatment
|
0 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
Serious events: 26 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 participants at risk
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 participants at risk
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 participants at risk
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Bone Tuberculosis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Breast Abscess
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Malaria
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
1.5%
2/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
1.5%
2/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Injury, poisoning and procedural complications
Foetal Exposure During Pregnancy
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Injury, poisoning and procedural complications
Maternal Exposure During Breast Feeding
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Threatened
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal Death
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Baby
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Pregnancy, puerperium and perinatal conditions
Premature Labour
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Psychiatric disorders
Acute Psychosis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
25.0%
1/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
2.2%
3/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Respiratory, thoracic and mediastinal disorders
Immature Respiratory System
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.73%
1/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
Other adverse events
| Measure |
Continued Treatment With DRV in Combination With Rtv:Children Less Than (<) 12 Years
n=4 participants at risk
HIV-1 infected children participants with dose level carried over from the corresponding parent studies received darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 28 months).
|
Continued Treatment With DRV in Combination With Rtv: Adolescents (12-17 Years)
n=4 participants at risk
HIV-1 infected adolescent participants with dose level carried over from the corresponding parent studies received DRV 200 to 600 milligrams (mg) as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID based on their body weight (maximum exposure duration: up to 39 months).
|
Continued Treatment With DRV in Combination With Rtv:Adults (Greater Than or Equal to [>=] 18 Years)
n=137 participants at risk
HIV-1 infected adult participants with dose level carried over from the corresponding parent studies received DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally twice daily (BID) along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229) (maximum exposure duration: up to 105 months).
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
0.00%
0/4 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
2.9%
4/137 • Up to 9 years 11 months
Full Analysis Set: participants had at least 1 dose DRV, regardless of protocol compliance and dose regimen adherence. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study included in single arm and combined analysis was performed as planned in protocol since the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
|
Additional Information
Director Clinical Development
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER