Last updated: 11/06/2025 13:50:13

Real-world experience of treatment-naïve people living with HIV who initiated treatment with single-tablet dolutegravir/lamivudine in a test-and-treat setting in Kuwait

GSK study ID
222254
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Non-Interventional Retrospective Observational single-centre cohort study on the effectiveness of using DTG/3TC in naïve people with HIV who initiated treatment in a test-and-treat setting in Kuwait
Trial description: This study will describe the clinical outcomes, demographics and clinical characteristics of treatment-naïve people living with human immunodeficiency virus (HIV) (PLWH) who were initiated on a fixed dose combination (FDC) of dolutegravir (DTG) plus lamivudine (3TC).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of participants who achieved viral suppression [HIV-1 RNA less than (<) 50 copies (c)/milliliter (mL)]

Timeframe: At Week 52 (end of the follow-up period)

Secondary outcomes:

Percentage of participants with virological failure (VF) [HIV-1 RNA concentration after suppression to <50 c/mL (HIV RNA VL levels greater than or equal to (≥) 200 c/mL (2 consecutive measurements)

Timeframe: Up to Week 52

Percentage of participants with virologic blips [single viral load measurements >50 c/mL and less than (<) 200 c/ml after suppression to <50 c/ml

Timeframe: Up to Week 52

Change from baseline in cluster of differentiation 4 (CD4) cell count

Timeframe: At Week 52 compared to Baseline (Day 1)

Percentage of participants with recorded confirmed acquired resistance to DTG or 3TC in participants who meet confirmed VF criteria

Timeframe: Up to Week 52

Percentage of participants who change first line regimen of DTG/3TC FDC due to baseline laboratory results or HIV-1 resistance mutation results

Timeframe: At Week 52

Percentage of participants who discontinued treatment, with reasons for discontinuation [stopping or changing regimen due to VF, adverse events (AE), others like Hepatitis B Virus (HBV), resistance] and subsequent therapy

Timeframe: Up to Week 52

Mean change from baseline in lipid parameters: total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides (TG)

Timeframe: At Week 52 compared to Baseline (Day 1)

Mean change from baseline in renal parameters: serum creatinine and eGFR

Timeframe: At Week 52 compared to Baseline (Day 1)

Mean change from baseline in TC/HDL ratio

Timeframe: At Week 52 compared to Baseline (Day 1)

Percentage of participants HIV-infected by route of infection [men who have sex with men (MSM]), heterosexual, blood transfusion, IV drug use, mother to child, needle stick injury, unknown

Timeframe: At Baseline (Day 1)

HIV-1 RNA concentration at time of treatment initiation (<100,000 c/mL and >=100,000 c/mL, missing)

Timeframe: At Baseline (Day 1)

CD4 cell count at time of treatment initiation (< and >200 cells/μL, missing)

Timeframe: At Baseline (Day 1)

Percentage of participants with a resistance profile (M184V) after receiving the results of the HIV-1 genotype testing

Timeframe: At Baseline (Day 1)

Number of participants with HBV coinfection

Timeframe: At Baseline (Day 1)

Number of participants with any comorbidities (hypertension, diabetes, hyperlipidaemia, hepatic impairment, renal impairment, other comorbidities)

Timeframe: At Baseline (Day 1)

Number of participants using any concomitant medication

Timeframe: At Baseline (Day 1)

Median time between confirmed diagnosis of HIV and initiation of antiretroviral treatment (ART)

Timeframe: At Baseline (Day 1)

Interventions:
Not applicable
Enrollment:
120
Primary completion date:
2025-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
HIV infections
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2025 to November 2025
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • To be eligible to participate in this study, a subject must meet all the following criteria:
  • 18 years of age
  • A subject who meets any of the following criteria will be excluded from participation in this study.
  • Patients initiating treatment with DTG/3TC after more than 14 days of first medical appointment with Infectious Diseases physicians following a confirmed diagnosis of HIV.
Inclusion and exclusion criteria
Inclusion criteria:

    To be eligible to participate in this study, a subject must meet all the following criteria:

    • 18 years of age
    • Have confirmed diagnosis of HIV-1
    • Treatment naïve PLWH initiated DTG/3TC as part of a test-and-treat (T&T) strategy (defined as starting Antiretroviral Treatment [ART] on the same day or within 14 days of first medical appointment with infectious diseases physician after confirmed diagnosis of HIV, in the absence of known lab-values for all or any of the following variables: HIV-1 RNA viral load, CD4+ cell count, hepatitis B serology and HIV-1 drug resistance genotype mutations)
    • Must have been initiated treatment on or after January 2021 and before 30 September 2024.
    • Patients switched from FDC DTG/3TC to DTG and 3TC as separate pills (due to shortage of supply of FDC DTG/3TC), then switched back again to FDC DTG/3TC during the index period; will still be included.
Exclusion criteria:

    A subject who meets any of the following criteria will be excluded from participation in this study.

    • Patients initiating treatment with DTG/3TC after more than 14 days of first medical appointment with Infectious Diseases physicians following a confirmed diagnosis of HIV.
    • Patients falling outside the index period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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