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)

English version

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
prolekare.web.journal.doi_sk: https://doi.org/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:

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

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