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Integrase Inhibitor

DTG 50 mg for Human Immunodeficiency Virus Infection

Phase 3
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ls baseline (week 48), weeks 56, 76, 100 and 148
Awards & highlights

Study Summary

This trial will test whether a 2-drug regimen of dolutegravir + rilpivirine is as effective as a 3-drug regimen including 2 nucleoside reverse transcriptase inhibitors for people with HIV who have undetectable viral loads.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ls baseline (week 48), weeks 56, 76, 100 and 148
This trial's timeline: 3 weeks for screening, Varies for treatment, and ls baseline (week 48), weeks 56, 76, 100 and 148 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm
Secondary outcome measures
Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
HIV Vaccine
Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class
+38 more
Other outcome measures
Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Late Switch Group Through Late Switch Phase
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Late Switch Group Through Late Switch Phase
+1 more

Side effects data

From 2020 Phase 3 trial • 113 Patients • NCT02178592
26%
Upper respiratory tract infection
11%
Headache
9%
Decreased appetite
9%
Lower respiratory tract infection
9%
Diarrhoea
9%
Urinary tract infection
6%
Gastroenteritis
6%
Pharyngitis
6%
Furuncle
6%
Bronchitis
6%
Blood creatinine increased
6%
Pruritus
6%
Influenza
6%
Viral upper respiratory tract infection
6%
Vomiting
4%
Cough
4%
Nasopharyngitis
4%
Neutropenia
4%
Blood pressure increased
2%
Cholecystitis acute
2%
Depression
2%
Body tinea
2%
Cerumen impaction
2%
Foetal death
2%
Rash
2%
Hyperemesis gravidarum
2%
Hypocalcaemic seizure
2%
Seizure
2%
Arthralgia
2%
Peptic ulcer
2%
Acarodermatitis
2%
Fungal skin infection
2%
Pain in extremity
2%
Lower limb fracture
2%
Myalgia
2%
Blood creatine phosphokinase increased
2%
Tonsillitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
DTG 50 mg- OLE Phase
EFV 600 mg- OLE Phase
DTG 50 mg- Randomized Phase
EFV 600 mg- Randomized Phase

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving DTG 50 mg + RPV 25 mgExperimental Treatment2 Interventions
Participants will receive DTG 50 mg + RPV 25 mg once daily from Day 1 through Week 148 (Early and Late Switch Phase).
Group II: Participants receiving CARActive Control1 Intervention
Participants will receive CAR from Day 1 to Week 52 (Early Switch Phase), and eligible participants will switch to DTG 50 milligrams (mg) + RPV 25 mg once daily from Week 52 to 148 (Late Switch Phase).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPV 25 mg
2015
Completed Phase 3
~1100
DTG 50 mg
2015
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
204,553 Total Patients Enrolled
ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,025 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,066,935 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
2015. "Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02422797.
~52 spots leftby Apr 2025
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