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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Participants will receive rilpivirine 25 mg tablet orally once daily.
Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.
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
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).
Time frame: Week 24
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).
Time frame: Week 24
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).
Time frame: Week 48
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.
Time frame: At Weeks 24 and 48
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.
Time frame: Baseline, Weeks 24 and 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 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.
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Deenanath Mangeshkar Hospital and Research Centre
Pune, India
Time frame: Through Week 48
Percentage of Participants with Laboratory Abnormalities
Percentage of participants with laboratory abnormalities will be reported.
Time frame: Up to Week 48
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.
Time frame: Baseline up to Week 48
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).
Time frame: Through Weeks 24 and 48
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.
Time frame: Up to Weeks 24 and 48