Clinical trial NCT03563742: A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Official title: Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus Infections
Keywords: Treatment-naive
rilpivirine
India
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive participants, as determined by the percentage of virologic responders defined as having HIV-1 ribonucleic acid (RNA) less than 400 copies/ milliliter (mL) at Week 24.


Eligibility criteria: Inclusion Criteria:

* Must have documented human immunodeficiency virus type 1 (HIV-1) infection
* Must be antiretroviral (ARV) treatment-naïve
* Have plasma HIV-1 ribonucleic acid (RNA) less than (\<) 100,000 copies/milliliter (mL) at screening visit
* Have cluster of CD4+ T-cell count (greater than) \>200/ cubic millimeter (mm\^3) at screening visit
* 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:

* 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) Society-United States (USA) (International Antiviral Society-USA) 2017 guidelines
* Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency)
* Diagnosed with acute viral hepatitis at screening or before baseline
* Infected with Mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study
* 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

Primary outcomes:
measure: Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at Week 24
timeFrame: Week 24
measure: Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48
timeFrame: Week 48
measure: Absolute Value in Cluster of Differentiation 4 Positive (CD4+) T-Cell Count at Weeks 24 and 48
timeFrame: At Weeks 24 and 48
measure: Change from Baseline in CD4+ T Cell Count at Weeks 24 and 48
timeFrame: Baseline, Weeks 24 and 48
measure: 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 48
timeFrame: Through Week 48
measure: Percentage of Participants with Laboratory Abnormalities
timeFrame: Up to Week 48
measure: Number of Participant with Clinically Significant Change from Baseline in Laboratory Parameters
timeFrame: Baseline up to Week 48
measure: Emergence of Viral Resistance Through Weeks 24 and 48
timeFrame: Through Weeks 24 and 48
measure: Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48
timeFrame: Up to Weeks 24 and 48
Other outcomes:
Locations:
city: Chennai
country: India
facility: Chennai Antiviral Research and Treatment(CART) Clinical Research Site
city: Chennai
country: India
facility: YRGCARE
city: Mangalore
country: India
facility: Manipal University-Kasturba Medical College
city: Nagpur
country: India
facility: Lata Mangeshkar Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: