The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
Name: darunavir 800 mg
Description: darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)Type: Drug3-drug standard therapy 5-drug experimental therapy
Name: FTC 200 mg/TDF 300mg
Description: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)Type: Drug3-drug standard therapy 5-drug experimental therapy
Name: Maraviroc
Description: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)Type: Drug5-drug experimental therapy
Name: Raltegravir
Description: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)Type: Drug5-drug experimental therapy
Name: Ritonavir 100 mg
Description: one tablet of ritonavir is taken with darunavir dailyType: Drug3-drug standard therapy 5-drug experimental therapy
Allocation: Randomized
Parallel Assignment
There are 6 SNPs
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L ---
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L --- --- I84V ---
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R ---
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V ---
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L --- --- I84V --- --- N88S ---
Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M ---