Trials / Terminated
TerminatedNCT03563742
A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilpivirine 25 mg | Participants will receive rilpivirine 25 mg tablet orally once daily. |
| 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. |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2021-06-28
- Completion
- 2021-06-28
- First posted
- 2018-06-20
- Last updated
- 2024-10-28
Locations
5 sites across 1 country: India
Source: ClinicalTrials.gov record NCT03563742. Inclusion in this directory is not an endorsement.