A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Human Immunodeficiency Virus Infections Clinical Trial

— RISE  

Official title:

Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03563742
• Other study ID #: CR108402
• Secondary ID: TMC278HTX3001
• Status: Terminated
• Phase: Phase 3
• Start date: September 24, 2018
• Est. completion date: June 28, 2021

Study information

• Verified date: June 2022
• Source: Johnson & Johnson Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Human Immunodeficiency Virus Infections
• Immunologic Deficiency Syndromes
• Infections

Intervention

Drug:
• Rilpivirine 25 mg
Participants will receive rilpivirine 25 mg tablet orally once daily.
• Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)
Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.

Locations

Country	Name	City	State
India	St.Johns Medical College and Hospital	Bengaluru
India	Chennai Antiviral Research and Treatment(CART) Clinical Research Site	Chennai
India	YRGCARE	Chennai
India	Manipal University-Kasturba Medical College	Mangalore
India	Lata Mangeshkar Hospital	Nagpur
India	Deenanath Mangeshkar Hospital and Research Centre	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pte Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who are Virologic Responders (HIV-1 RNA <400 Copies/mL) at Week 24	Virologic responders are defined as participants having viral load (plasma Human Immunodeficiency Virus-Type 1 Ribonucleic Acid [HIV-1 RNA] levels) less than (<) 400 copies/milliliter (mL) at Week 24 (Food and Drug Administration [FDA]-defined snapshot analysis).	Week 24
Secondary	Percentage of Participants who are Virologic Responders (HIV-1 RNA <50 Copies/mL) at Week 24	Virologic responders are defined as participants having viral load (plasma HIV-1 RNA levels) <50 copies/mL at Week 24 (FDA-defined snapshot analysis).	Week 24
Secondary	Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48	Virologic responders are defined as participants having viral load (plasma HIV-1 RNA levels) <50, <400 and <1,000 copies/mL at Week 48 (FDA-defined snapshot analysis).	Week 48
Secondary	Absolute Value in Cluster of Differentiation 4 Positive (CD4+) T-Cell Count at Weeks 24 and 48	CD4+T cell absolute counts will be determined at Weeks 24 and 48.	At Weeks 24 and 48
Secondary	Change from Baseline in CD4+ T Cell Count at Weeks 24 and 48	Change from baseline in CD4+ T cell count will be determined at Weeks 24 and 48.	Baseline, Weeks 24 and 48
Secondary	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	Percentage of participants with Grade 3 and 4 AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants who prematurely discontinued study due to AEs will also be analyzed.	Through Week 48
Secondary	Percentage of Participants with Laboratory Abnormalities	Percentage of participants with laboratory abnormalities will be reported.	Up to Week 48
Secondary	Number of Participant with Clinically Significant Change from Baseline in Laboratory Parameters	Number of participants with clinically significant change from baseline in laboratory parameters related to hematology, serum chemistry will be assessed.	Baseline up to Week 48
Secondary	Emergence of Viral Resistance Through Weeks 24 and 48	Resistance analysis will be determined using genotypic analysis at the time of virological failure (that is, 2 consecutive plasma HIV-1 RNA levels greater than or equal to [>=] 400 copies/mL through Weeks 24 and 48 of study treatment).	Through Weeks 24 and 48
Secondary	Percentage of Participant with Treatment Adherence (95%) Based on Tablet Count up to Weeks 24 and 48	Percentage of adherent participants as measure of treatment compliance will be assessed by tablet count.	Up to Weeks 24 and 48

External Links

•   Open-Label Study with Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy