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There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC+3TC+DTG | Active Comparator | Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen |
|
| ABC+3TC+DRV/r | Active Comparator | Abacavir+lamivudine+ritonavir-boosted darunavir, QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug |
| ||
| Darunavir/r |
| Measure | Description | Time Frame |
|---|---|---|
| Median CD4 T cell count increase | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | BCN | 08013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41083105 | Derived | Miro JM, Torres F, Manzardo C, Bonfill E, Curran A, Domingo P, Podzamczer D, Paredes R, Force L, Falco V, Gutierrez M, Saumoy M, Castelli A, Inciarte A, Rovira C, Cruceta A, Hurtado C, Climent N, Lozano F, Plana M; Advanz-4 investigators. Immune reconstitution in very advanced HIV patients treated with dolutegravir vs. darunavir-based triple antiretroviral therapy: the Advanz-4 randomized clinical trial. Clin Microbiol Infect. 2026 Jan;32(1):169-176. doi: 10.1016/j.cmi.2025.09.026. Epub 2025 Oct 11. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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|
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |