Health Condition 1: B20- Human immunodeficiency virus [HIV]disease
Conditions
Interventions
Intervention1: Treatment: Rilpivirine Combination Therapy (TDF/3TC): The participants will receive antiretroviral treatment of rilpivirine 25 milligram (mg) tablet orally once daily from Day 1 for 48
Sponsors
Johnson Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Must have documented human immunodeficiency virus type 1 (HIV-1) infection 2. Must be antiretroviral (ARV) treatment-naïve 3. Have plasma HIV-1 ribonucleic acid (RNA) less than 100,000 copies/milliliter (mL) at screening visit 4. Have cluster of CD4+ T-cell count (greater than) 200/ cubic millimeter (mm3) at screening visit 5. Women of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta hCG]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study
Exclusion criteria
Exclusion criteria: 1. History of any primary nucleo(t)side reverse transcriptase inhibitor (N[t]RTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations (if testing performed locally, and results are available), as defined by the current International AIDS (acquired immunodeficiency syndrome) Societyâ??United States (USA) (International Antiviral Society-USA) 2017 guidelines 2. Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency) 3. Diagnosed with acute viral hepatitis at screening or before baseline 4. Infected with Mycobacterium tuberculosis which is likely to require rifampicin based treatment during the study 5. Has a Grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) for Grading the Severity of Adult and Pediatric Adverse Events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) Preexisting diabetes or with asymptomatic glucose Grade 3 or 4 elevations (b) Asymptomatic triglyceride or cholesterol elevations of Grade 3 or 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who are Virologic Responders (HIV-1 RNA 400 Copies/mL) at Week 24Timepoint: Percentage of Participants who are Virologic Responders (HIV-1 RNA 400 Copies/mL) at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Value in Cluster of Differentiation 4 Positive (CD4) T-Cell Count at Weeks 24 and 48Timepoint: At Weeks 24 and 48;Change from Baseline in CD4 T Cell Count at Weeks 24 and 48Timepoint: Baseline, Weeks 24 and 48;Change from Baseline in Laboratory ParametersTimepoint: Up to Week 48;Emergence of Viral Resistance Through Weeks 24 and 48Timepoint: Through Weeks 24 and 48;Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48Timepoint: Up to Weeks 24 and 48;Percentage of Participants who are Virologic Responders (HIV-1 RNA 50 Copies/mL) at Week 24Timepoint: Week 24;Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels 50, 400 and 1,000 Copies/mL) at Week 48Timepoint: Week 48;Percentage of Participants with Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Participants Experiencing Premature Discontinuation due to AEs Through Week 48Timepoint: Through Week 48;Percentage of Participants with Laboratory AbnormalitiesTimepoint: Up to Week 48 | — |
Countries
India
Contacts
Public ContactDr Sanish Davis
Johnson & Johnson Private Limited
Outcome results
None listed