Dolutegravir-based Dual Therapies in HIV-infected Patients With Virological Suppression (DOLBI)
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ClinicalTrials.gov Identifier: NCT02491242 |
Recruitment Status :
Completed
First Posted : July 8, 2015
Last Update Posted : July 2, 2018
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Condition or disease | Intervention/treatment |
---|---|
HIV Infection | Other: Dolutegravir in a dual therapy regimen |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 155 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | The Efficacy and Safety of Dolutegravir-based Dual Therapies in HIV-infected Patients With Intolerance or Toxicity to Nucleoside Analogues |
Actual Study Start Date : | November 2015 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | June 2018 |
- Other: Dolutegravir in a dual therapy regimen
None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year
- 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
- 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
- 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
- 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).
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491242
Spain | |
Ramon y Cajal Hospital | |
Madrid, Spain, 28034 |
Principal Investigator: | Jose L Casado, MD, PhD | Ramon y Cajal Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jose L. Casado, Physician, MD, PhD, Asociacion para el Estudio de las Enfermedades Infecciosas |
ClinicalTrials.gov Identifier: | NCT02491242 |
Other Study ID Numbers: |
Dolbi |
First Posted: | July 8, 2015 Key Record Dates |
Last Update Posted: | July 2, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
HIV dolutegravir intolerance dual therapies |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Dolutegravir HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |