Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir
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ClinicalTrials.gov Identifier: NCT02337322 |
Recruitment Status : Unknown
Verified August 2018 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : August 3, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Immune Deficiency Syndrome Virus | Drug: Dolutegravir Drug: Darunavir/r | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial). |
Actual Study Start Date : | March 31, 2015 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: ABC+3TC+DTG
Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen
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Drug: Dolutegravir |
Active Comparator: ABC+3TC+DRV/r
Abacavir+lamivudine+ritonavir-boosted darunavir, QD
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Drug: Darunavir/r
Other Name: Ritonavir-boosted Darunavir |
- Median CD4 T cell count increase [ Time Frame: 48 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV patients > 18 years old who provide signed and dated informed consent.
- Male and female.
- Chronic HIV infection.
- Antiretroviral naïve.
- Confirmed CD4+ T cell count below 100 cells/mm3
- HLA B5701 negative patients.
Exclusion Criteria:
- Active opportunistic infections requiring parenteral treatment
- Patients with cryptococcal meningitis treated with voriconazole
- AIDS-defining cancers needing chemotherapy.
- Female patients pregnant or breastfeeding.
- Patients with documented history of allergy to sulfonamides.
- Any contraindications to study drugs.

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): NCT02337322
Spain | |
Hospital Clinic of Barcelona | |
Barcelona, BCN, Spain, 08013 |
Responsible Party: | Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT02337322 |
Other Study ID Numbers: |
Advanz-4 |
First Posted: | January 13, 2015 Key Record Dates |
Last Update Posted: | August 3, 2018 |
Last Verified: | August 2018 |
Acquired Immune Deficiency Syndrome Virus HIV HIV-1 Antiretroviral treatment |
HIV Advanced Disease AIDS Dolutegravir Darunavir |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Ritonavir |
Darunavir Dolutegravir HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors HIV Integrase Inhibitors Integrase Inhibitors |