A prospective randomized trial on abacavir/lamivudine plus darunavir/ritonavir or raltegravir in HIV-positive drug-naïve patients with CD4<200 cells/uL (the PRADAR study)


Autoři: Cristina Mussini aff001;  Enrica Roncaglia aff001;  Vanni Borghi aff001;  Stefano Rusconi aff002;  Silvia Nozza aff003;  Anna Maria Cattelan aff004;  Daniela Segala aff005;  Paolo Bonfanti aff006;  Antonio Di Biagio aff007;  Enrico Barchi aff008;  Emanuele Focà aff009;  Anna Degli Antoni aff010;  Stefano Bonora aff011;  Daniela Francisci aff012;  Silvia Limonta aff002;  Andrea Antinori aff013;  Gabriella D’Ettorre aff014;  Franco Maggiolo aff015
Působiště autorů: Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Modena, Italy aff001;  Clinic of Infectious Diseases, DIBIC Luigi Sacco, University of Milan, Milan, Italy aff002;  Clinic of Infectious Diseases, University Vita e Salute, San Raffaele Hospital, Milan, Italy aff003;  Clinic of Infectious Diseases, Padova Hospital, Padova, Italy aff004;  Clinic of Infectious Diseases, Sant’Anna Hospital, Ferrara, Italy aff005;  Department of Infectious Diseases, Lecco Hospital, Lecco, Italy aff006;  Clinic of Infectious Diseases, San Martino Hospital, Genova, Italy aff007;  Department of Infectious Diseases, Santa Maria Nuova Hospital, Reggio Emilia, Italy aff008;  Clinic of Infectious Diseases, University of Brescia and ASST Spedali Civili, Brescia, Italy aff009;  Clinic of Infectious Diseases, University of Parma, Parma, Italy aff010;  Clinic of Infectious Diseases, University of Torino, Torino, Italy aff011;  Clinic of Infectious Diseases, University of Perugia, Perugia, Italy aff012;  National Institute for Infectious Diseases L. Spallanzani, Rome, Italy aff013;  Clinic of Infectious Diseases, University La Sapienza, Rome, Italy aff014;  Department of Infectious Diseases, Bergamo Hospital, Bergamo, Italy aff015
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222650

Souhrn

Background

Very few data are available on treatment in HIV Late presenter population that still represents a clinical challenge.

Methods

Prospective, multicenter, randomized open-label, 2 arm, phase-3 trial comparing the 48-week virological response of two different regimens: abacavir/lamivudine + darunavir/r vs abacavir/lamivudine + raltegravir in antiretroviral naive with CD4+ counts < 200/mm3 and a viral load (VL)<500,000 copies/mL. The primary Endpoint was the proportion of patients with undetectable viremia (VL<50 copies/mL) after 48 weeks. The planned sample size for this trial was 350 patients.

Results

In 3 years, 53 patients were screened and 46 enrolled: 22 randomized to raltegravir and 24 to darunavir/r; 7 patients were excluded, 4 because of a VL >500,000 copies/mL and 3 for HLAB5701 positivity. The snapshot analysis at 48 weeks showed a virologic success of 77.3% in raltegravir and 66.7% in darunavir/r. Time to starting treatment was 34.5 days in raltegravir and 53 days in darunavir/r. At the as treated analysis, the median CD4 counts at 48 weeks was 297 cells/μL in raltegravir and 239 cells/μL in darunavir/r. No difference in total cholesterol, while triglycerides were higher in the darunavir/r arm. No statistical analyses were performed due to the low number of patients enrolled.

Conclusions

Late presenter patients are frequent but very difficult to enroll in clinical trials, especially in western countries. These regimens and the conditions of many patients could not allow the test and treat strategy. The rate of virologic success was higher than 65% in both arms with a median CD4 cell count >200/μL at week 48.

Trial registration

EUDRACT number: 2011-005973-21

Klíčová slova:

Adverse events – Antiretroviral therapy – Antiretrovirals – HIV – HIV diagnosis and management – Cholesterol – Viral load – Opportunistic infections


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