Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC278HTX3001 | Other Identifier | Johnson & Johnson Pte Ltd |
Not provided
Not provided
High SF rate (less treatment-naïve subjects & subjects with viral load <100000). Reevaluation in scientific position in India after internal discussion.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: Rilpivirine+Combination Therapy (TDF/3TC) | Experimental | The participants will receive antiretroviral treatment of rilpivirine 25 milligram (mg) tablet orally once daily from Day 1 for 48 weeks with a meal to improve absorption. The participants will also receive background combination therapy of 1 tablet orally once daily containing 300 mg tenofovir disoproxil fumarate (TDF) and 300 mg lamivudine (3TC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine 25 mg | Drug | Participants will receive rilpivirine 25 mg tablet orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participants who are Virologic Responders (Plasma HIV-1 RNA Levels <50, <400 and <1,000 Copies/mL) at Week 48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chennai Antiviral Research and Treatment(CART) Clinical Research Site | Chennai | 600113 | India | |||
| YRGCARE |
Not provided
| Label | URL |
|---|---|
| Open-Label Study with Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC) | Drug | Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| Percentage of Participants with Laboratory Abnormalities | Percentage of participants with laboratory abnormalities will be reported. | 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. | 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). | 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. | Up to Weeks 24 and 48 |
| Chennai |
| 600113 |
| India |
| Manipal University-Kasturba Medical College | Mangalore | 575001 | India |
| Lata Mangeshkar Hospital | Nagpur | 440001 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | 411004 | India |
| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided