← Back to Search

Antiretroviral

DTG/3TC FDC 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 baseline (day 1) and week 76, week 100, and week 132
Awards & highlights

Study Summary

This trial is testing whether or not switching to a new drug combination (dolutegravir/lamivudine) is as effective as continuing a current antiretroviral regimen in suppressing the Human Immunodeficiency Virus (HIV). The study will last for up to 52 weeks and will involve 490 participants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and week 76, week 100, and week 132
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and week 76, week 100, and week 132 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Secondary outcome measures
Change From Baseline in CD4+ Cell Count for Week 48
Change From Baseline in CD4+/ Cluster of Differentiation 8 (CD8+) Cell Counts Ratio for Week 24
Change From Baseline in CD4+/CD8+ Cell Counts Ratio for Week 48
+23 more

Side effects data

From 2022 Phase 3 trial • 493 Patients • NCT04021290
8%
Weight increased
7%
Headache
6%
COVID-19
6%
Back pain
6%
Insomnia
5%
Dizziness
4%
Syphilis
4%
Nasopharyngitis
4%
Upper respiratory tract infection
3%
Diarrhoea
2%
Myalgia
2%
Rash
2%
Renal impairment
2%
Hyperlipidaemia
2%
Fatigue
2%
Hypertension
2%
Gastrooesophageal reflux disease
2%
Oropharyngeal pain
2%
Nausea
2%
Dermatitis
2%
Arthralgia
2%
Anxiety
2%
Neck pain
2%
Pyrexia
2%
Pain in extremity
2%
Dyspepsia
2%
Abdominal distension
2%
Abdominal pain
1%
Low density lipoprotein increased
1%
Respiratory tract infection
1%
Pharyngitis
1%
Dermatitis allergic
1%
Gastroenteritis
1%
Anaemia
1%
Erectile dysfunction
1%
Vaginal haemorrhage
1%
Asthenia
1%
Chest discomfort
1%
Abdominal pain lower
1%
Rhinitis
1%
Urinary tract infection
1%
Acne
1%
Conjunctivitis
1%
Cystitis
1%
Lymphadenopathy
1%
Increased appetite
1%
Sleep disorder
1%
Abdominal pain upper
1%
Blood glucose increased
1%
Cataract
1%
Memory impairment
1%
Type 2 diabetes mellitus
1%
Loss of libido
1%
Metabolic syndrome
1%
Oral herpes
1%
Influenza like illness
1%
Gastrointestinal infection
1%
Ear pain
1%
Periodontitis
1%
Pharyngotonsillitis
1%
Hypercholesterolaemia
1%
Vomiting
1%
Bronchitis
1%
Cough
1%
Blood creatinine increased
1%
Respiratory disorder
1%
Oropharyngeal gonococcal infection
1%
Chlamydial infection
1%
Herpes zoster
1%
Blood creatine phosphokinase increased
1%
Blood cholesterol increased
1%
Dental caries
1%
Muscle spasms
1%
Flatulence
1%
Toothache
1%
Onychomycosis
1%
Hyperglycaemia
1%
Decreased appetite
1%
Alopecia
1%
Vertigo
1%
Glomerular filtration rate decreased
1%
Hot flush
1%
Depression
1%
Rhinitis allergic
1%
Meniscus injury
1%
Benign breast neoplasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Phase-Participants Who Received DTG/3TC FDC
Randomized Phase-Participants Who Received CAR
Continuation Phase-Participants Who Received DTG/3TC FDC

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving DTG/3TC FDCExperimental Treatment1 Intervention
Eligible participants will be randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from Day 1 up to 52 weeks. Participants who complete 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
Group II: Participants receiving CARActive Control1 Intervention
Eligible participants will continue to receive CAR from Day 1 up to 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DTG/3TC FDC
2019
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,050 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,066,959 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,422 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/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)
2019. "Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04021290.
~91 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top