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Completed

NCT Number: NCT02491242

Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression

The objective of this study was to evaluate the efficacy and safety, and evolution of causes leading to change, of dual therapies based in Dolutegravir in patients requiring a change of virologically effective antiretroviral therapy.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections 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

Ramon y Cajal Hospital

Madrid, 28034, Spain

About this study

Despite the high rate of virological suppression and low risk of toxicity, HIV-infected patients continue to need new antiretroviral strategies, such as dual therapies, because of different end-organ involvement (kidney, bone, cardiovascular..), intolerance or toxicity. To date, only a protease inhibitor (PI)-based regimen was able to permit the use of dual therapies (two antiretrovirals), especially in case of patients with history of virological failure to other regimens. However, the recent license of Dolutegravir, a integrase inhibitor with high genetic barrier, could help to clinicians to manage patients with intolerance or toxicity to nucleoside analogues without putting in risk virological suppression.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Older than 18 years
  • Receiving a virologically effective antiretroviral regimen
  • Switching to a dual therapy based in dolutegravir because of intolerance or toxicity to nucleoside analogues

Exclusion criteria

  • Pregnant women
  • Receiving other investigational drugs
  • Recent diagnosis of opportunistic infection (< 1 month)

Treatment and study plan

Dolutegravir in a dual therapy regimen

Other

None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year

Primary outcomes

  1. Efficacy, measured as maintenance of virological suppression, after switching to a dolutegravir-based dual therapy

    Time frame: 12 months

    Percent of patients remaining with HIV RNA level below 50 copies/ml, according to a missing=failure criteria

Secondary outcomes

  1. Safety according to DAIDS grade events 2009 of dual therapy based in dolutegravir

    Time frame: 12 months

    To collect adverse events (according to DAIDS grade events, 2009) and rate of discontinuation related with adverse events, of dual therapy after switching

  2. Outcome of causes leading to switch the previous regimen

    Time frame: 12 months

    Evolution of causes de change: glomerular filtration rate during evolution, tubular dysfunction (proteinuria, phosphaturia, glycosuria, uricosuria),bone mineral density by DXA (dual X-ray absorptiometry), lipid disorders, adherence

  3. Efficacy, measured as maintenance of virological suppression, of different dual therapies with dolutegravir

    Time frame: 12 months

    Comparison of efficacy (HIV RNA level < 50 c/ml) of the different dolutegravir-based dual therapies, according to accompanying drug (non nucleoside, especially rilpivirine), protease inhibitors (darunavir boosted with ritonavir or cobicistat), or nucleoside analogues (lamivudine).

Other outcomes

  1. Rate of virological suppression in patients with previous failure to more than 2 families of antiretroviral drugs

    Time frame: 12 months

    Effect of extended previous failure, or mutations in the transcriptase and protease gene, in the rate of virological suppression in dolutegravir-based dual therapies

Sponsors and collaborators

Lead sponsor

Asociacion para el Estudio de las Enfermedades Infecciosas

Network

Registry information

Official study title

The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues

Acronym: DOLBI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 8, 2015
Registry last updated
Jul 2, 2018

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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