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Completed

NCT Number: NCT04019873

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Barcelona, 08041, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • No specific exclusion criteria

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: At Week 48

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

    Time frame: At Week 96

  4. Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24

    Time frame: At Week 24

  5. Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48

    Time frame: At Week 48

  6. Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96

    Time frame: At Week 96

  7. 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).

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Secondary outcomes

  1. 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

  2. Number of Participants With Low Level Viremia

    Time frame: At Week 24, Week 48 and Week 96

    Low level viremia was defined as virologic load >=50 and <200 c/mL.

  3. Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression

    Time frame: Up to Week 96

    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.

  4. Time to Virologic Failure in the Stable Switch Population

    Time frame: Up to Week 96

    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).

  5. Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events

    Time frame: Up to Week 96

  6. 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

    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.

  7. Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure

    Time frame: Up to Week 96

    Virologic rebound or virologic non-response in participants, was considered as virologic failure.

  8. Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons

    Time frame: Up to Week 96

    Safety reasons include tolerability, toxicity and other reasons.

  9. Number of Participants With AEs and SAEs

    Time frame: Up to Week 96

    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.

  10. Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts

    Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96

  11. CD4/CD8 Ratio

    Time frame: At baseline (Week 0), Week 24, Week 48 and Week 96

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2019
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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