Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial).

Conditions: tratement HIV infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-002281-70-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. chronic infection by HIV-1.
2. equal to or more than 18 years old.
3 that you have not previously received anti-retroviral treatment.
4 digit baseline CD4 count 100 Celsµl (confirmed by two determinations).
5 result of baseline genotypic resistance study showing absence of mutations of resistance to drugs in the study.
6 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known hypersensitivity to drugs in the study.
2. hypersensitivity documented to sulfonamides and derivatives.
3 positivity in the determination of the HLA B5701.
4 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
5 lymphomas and other active Neoplasms that require chemotherapy.
6. less than 50 mlmin creatinine clearance.
7 liver failure moderate or severe (Child-Pugh classification C class).
8 ALT ?5 times the upper limit of normal (ULN), or ALT ?3 times the ULN and total bilirubin ?1, 5 times the ULN (with 35 of direct bilirubin).
9. need for treatment of HCV during the study.
10. current or recent treatment with nephrotoxic drugs.
11. treatment with immunomodulators, or products under investigation.
12. treatment with drugs or products whose pharmacokinetic interaction potential decrease efficiency or increase the toxicity of antiretroviral drugs in the study.
13. any formal contraindication to be treated with the drugs in the study.