Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1 (JUNGLE)

ViiV Healthcare

Status: Completed

Conditions: HIV Infections

Treatments: Drug: JULUCA

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03518060

208982

Details and patient eligibility

About

This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greated than or equal to (>=)18 years of age.
• Documented HIV-1 infection.
• Virologically suppressed (HIV-1 ribonucleic acid [RNA] less than [<] 50 copies [c]/mL for at least 6 months)
• Prescription for JULUCA was issued independently from entering this study.
• Ability to understand informed consent form and other relevant study documents

Exclusion criteria

• Any contraindication according to JULUCA SmPC.
• Documented viral load greater than (>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
• History of treatment failure.
• Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
• Any ART for the treatment of HIV-1 in addition to JULUCA.
• Hepatitis B virus (HBV)-co-infection.
• Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
• Previous participation in clinical trials involving JULUCA.

Trial design

209 participants in 1 patient group

Participants who received JULUCA

Description:

Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.

Treatment:

Drug: JULUCA