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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2021-06-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Immunodeficiency Virus Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 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).

Group Type EXPERIMENTAL

Rilpivirine 25 mg

Intervention Type DRUG

Participants will receive rilpivirine 25 mg tablet orally once daily.

Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)

Intervention Type DRUG

Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.

Interventions

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Rilpivirine 25 mg

Participants will receive rilpivirine 25 mg tablet orally once daily.

Intervention Type DRUG

Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)

Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.

Intervention Type DRUG

Other Intervention Names

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Edurant Tenvir-L

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No