At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above
In Brief
A Phase 3 clinical trial evaluating Darunavir and Ritonavir for HIV-1 Infections. Completed, enrolled 145 participants across 17 sites in 8 countries.
Detailed Summary
The primary objective of this trial is to continue the provision of darunavir/ low-dose ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of darunavir in combination with low-dose ritonavir (DRV/rtv), in countries where DRV is not commercially available for the subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program) and to provide DRV through this trial until the participants can switched to locally available DRV-based treatment regimens (that is commercially available and reimbursed, or accessible through another source \[for example, access program or government program\]) or to local standard of care, as appropriate.
Study Details
Timeline
Interventions
Participants will receive darunavir (per parent study) as oral suspension.
Participants will receive ritonavir (per parent study) as oral solution/suspension.