Human Immunodeficiency Virus 1 MedDRA version: 20.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: REKAMBYS
Product Name: Rilpivirine
Pharmaceutical Form: Prolonged-release suspension for injection
INN or Proposed INN: Rilpivirine
Other descriptive name: RPV
Concentration unit: mg/ml mi
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study. 2. Participants living with HIV-1 infection who were treated in any of the parent studies and completed the protocol-defined treatment period. 3. Has benefited clinically from treatment in the opinion of the investigator. 4. Must be able and willing to comply with the rollover protocol requirements. 5. Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study. Are the trial subjects under 18? yes Number of subjects for this age range: 214 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participants using disallowed concomitant treatment. 2. Participants who were withdrawn from the previous parent study that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to provide continued access to participants who were enrolled and treated in the parent studies, and who, at the time of rollover experience clinical benefit from this treatment.;Secondary Objective: The secondary objective is to assess the long-term safety and tolerability of CAB + RPV by evaluating the incidence of serious adverse events, pregnancies, and adverse events.;Primary end point(s): No primary endpoint is defined for this study.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety laboratory tests may be performed, as determined necessary by the investigator or required by local regulations at any time during the participant’s participation in the study. Assessments will be performed per local standard of care and not collected in the eCRF; no additional study-specific blood sampling will be required.;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Countries
Botswana, Kenya, South Africa, Thailand, Uganda
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed