HIV InfectionsNCT04019873

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

An observational study of HIV Infections, run by ViiV Healthcare at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Dolutegravir (DTG), Lamivudine (3TC) and Rilpivirine (RPV)
How many people: 774 participants
Where: 1 siteSpain
Study dates: 18 Nov 2019to 5 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: The study population will consist of HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.

Who may be able to join

HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.

Who cannot join

No specific exclusion criteria

Trial locations and contacts

1 site in 1 country.

Spain1 site

GSK Investigational Site
Barcelona, 08041

Other trials in Spain

About this study

Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.

Conditions: HIV Infections
Being tested: Dolutegravir (DTG), Lamivudine (3TC), Rilpivirine (RPV)
Keywords: 2DR, HIV, Lamivudine, COMBINE-2, Dolutegravir
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dolutegravir (DTG)Drug
DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.
Lamivudine (3TC)Drug
3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.
Rilpivirine (RPV)Drug
RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.

Study groups in NCT04019873
Study group	Role	What they receive
Treatment-naïve participants		Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection. Receives: Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC); Drug: Rilpivirine (RPV)
Stable switch participants		Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment. Receives: Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC); Drug: Rilpivirine (RPV)
Prior virological failure participants		Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment. Receives: Drug: Dolutegravir (DTG); Drug: Lamivudine (3TC); Drug: Rilpivirine (RPV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation
Measured: At Week 24
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation
Measured: At Week 48
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation
Measured: At Week 96
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24
Measured: At Week 24
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48
Measured: At Week 48
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96
Measured: At Week 96
Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 24 weeks of treatment).
Measured: Up to 24 weeks
Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 48 weeks of treatment).
Measured: Up to 48 weeks
Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 96 weeks of treatment).
Measured: Up to 96 weeks
Number of Stable Switch Participants With VF Within the First 24 Weeks
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Measured: Up to Week 24
Number of Stable Switch Participants With VF Within the First 48 Weeks
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Measured: Up to Week 48
Number of Stable Switch Participants With VF Within the First 96 Weeks
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Measured: Up to Week 96
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 24 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Measured: Up to 24 weeks
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 48 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Measured: Up to 48 weeks
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks]
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 96 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Measured: Up to 96 weeks

Secondary outcomes (11)

Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks
Measured: At Week 24, Week 48 and Week 96
Number of Participants With Low Level Viremia
Low level viremia was defined as virologic load >=50 and <200 c/mL.
Measured: At Week 24, Week 48 and Week 96
Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression
Suppression of VL was evaluated at 24 weeks, 48 weeks and 96 weeks and time to virologic suppression was planned to be evaluated until 96 weeks.
Measured: Up to Week 96
Time to Virologic Failure in the Stable Switch Population
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 48 weeks of treatment).
Measured: Up to Week 96
Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events
Measured: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch
A stable switch was defined as a switching option for participants with HIV RNA suppression on current treatment with viral load <50 c/mL at time of switch.
Measured: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure
Virologic rebound or virologic non-response in participants, was considered as virologic failure.
Measured: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons
Safety reasons include tolerability, toxicity and other reasons.
Measured: Up to Week 96
Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Determination of an event as AE or SAE was at the discretion of the treating clinician and taken from the medical record.
Measured: Up to Week 96
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts
Measured: At baseline (Week 0), Week 24, Week 48 and Week 96
CD4/CD8 Ratio
Measured: At baseline (Week 0), Week 24, Week 48 and Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 20195 Dec 2023

First posted15 Jul 2019
Study start18 Nov 2019
Primary completion14 Apr 2023
Study completion5 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 774 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04019873
Sponsor's protocol ID: 207859
Status last verified: Dec 2024
First submitted: 19 Jul 2018
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
ClinicalTrials.gov ID: NCT04019873
Acronym / sponsor ID: 207859
Conditions: HIV Infections
Keywords: 2DR, HIV, Lamivudine, COMBINE-2, Dolutegravir
Study type: Observational
Recruitment status: Completed
Enrolment: 774 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Study start: 18 Nov 2019 (actual)
Primary completion: 14 Apr 2023 (actual)
Study completion: 5 Dec 2023 (actual)
First posted: 15 Jul 2019 (actual)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Treatment-naïve participants	–	Drug: Dolutegravir (DTG), Drug: Lamivudine (3TC), Drug: Rilpivirine (RPV)Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.
Stable switch participants	–	Drug: Dolutegravir (DTG), Drug: Lamivudine (3TC), Drug: Rilpivirine (RPV)Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.
Prior virological failure participants	–	Drug: Dolutegravir (DTG), Drug: Lamivudine (3TC), Drug: Rilpivirine (RPV)Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: The study population will consist of HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.

Key inclusion criteria (1 listed)

HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.

Key exclusion criteria (1 listed)

No specific exclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dolutegravir (DTG)DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.	Drug	Prior virological failure participants, Stable switch participants, Treatment-naïve participants
Lamivudine (3TC)3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.	Drug	Prior virological failure participants, Stable switch participants, Treatment-naïve participants
Rilpivirine (RPV)RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.	Drug	Prior virological failure participants, Stable switch participants, Treatment-naïve participants

Primary outcome

Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation
Time frame: At Week 24
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation
Time frame: At Week 48
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation
Time frame: At Week 96
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24
Time frame: At Week 24
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48
Time frame: At Week 48
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96
Time frame: At Week 96
Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks]
Time frame: Up to 24 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 24 weeks of treatment).
Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks]
Time frame: Up to 48 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 48 weeks of treatment).
Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks]
Time frame: Up to 96 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to [>=] 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL>=200 copies/mL after at least 96 weeks of treatment).
Number of Stable Switch Participants With VF Within the First 24 Weeks
Time frame: Up to Week 24
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Number of Stable Switch Participants With VF Within the First 48 Weeks
Time frame: Up to Week 48
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Number of Stable Switch Participants With VF Within the First 96 Weeks
Time frame: Up to Week 96
VF was defined as 2 consecutive HIV RNA >=50 c/mL or 1 HIV RNA >50c/mL followed by study treatment discontinuation or missing value.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks]
Time frame: Up to 24 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 24 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks]
Time frame: Up to 48 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 48 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks]
Time frame: Up to 96 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA >= 50 copies/mL or 1 HIV RNA level >=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL >=200 copies/mL after at least 96 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.

11 secondary outcomes

Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks
Time frame: At Week 24, Week 48 and Week 96
Number of Participants With Low Level Viremia
Time frame: At Week 24, Week 48 and Week 96
Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression
Time frame: Up to Week 96
Time to Virologic Failure in the Stable Switch Population
Time frame: Up to Week 96
Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events
Time frame: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch
Time frame: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure
Time frame: Up to Week 96
Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons
Time frame: Up to Week 96
Number of Participants With AEs and SAEs
Time frame: Up to Week 96
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts
Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96
CD4/CD8 Ratio
Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment-naïve Participants	23	22
Stable Switch Participants	735	696
Prior Virological Failure Participants	16	14

Primary outcome: Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation

Time frame: At Week 24. Count of participants. Unit: Participants

Measure	Treatment-naïve Participants n = 20
Value	19

Population analysed: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Primary outcome: Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation

Time frame: At Week 48. Count of participants. Unit: Participants

Measure	Treatment-naïve Participants n = 19
Value	19

Population analysed: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 48-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Primary outcome: Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation

Time frame: At Week 96. Count of participants. Unit: Participants

Measure	Treatment-naïve Participants n = 20
Value	20

Population analysed: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 96-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Primary outcome: Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24

Time frame: At Week 24. Count of participants. Unit: Participants

Measure	Prior Virological Failure Participants n = 16
Value	14

Population analysed: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment-naïve Participants	1 of 23 (4.3%)	1 of 23 (4.3%)	0 of 23
Stable Switch Participants	2 of 735 (0.3%)	39 of 735 (5.3%)	0 of 735
Prior Virological Failure Participants	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

ViiV Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by ViiV Healthcare at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation (time frame: At Week 24). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.