Clinical trial NCT00537394 (phase 3, status: completed)
Conditions: hiv infections
ICD codes: Z21
Drugs: enfuvirtide, raltegravir, darunavir, tipranavir, etravirine, maraviroc
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O, CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, [H][C@@]12CCO[C@]1([H])OC[C@@H]2OC(=O)N[C@@H](CC1=CC=CC=C1)[C@H](O)CN(CC(C)C)S(=O)(=O)C1=CC=C(N)C=C1, [H][C@@](CC)(C1=CC(NS(=O)(=O)C2=NC=C(C=C2)C(F)(F)F)=CC=C1)C1=C(O)C[C@@](CCC)(CCC2=CC=CC=C2)OC1=O, CC1=CC(=CC(C)=C1OC1=C(Br)C(N)=NC(NC2=CC=C(C=C2)C#N)=N1)C#N, CC(C)C1=NN=C(C)N1[C@H]1C[C@@H]2CC[C@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection

          -  Triple-class drug experience or resistance. More information on this criterion can be
             found in the protocol.

          -  Currently on a failing PI-containing regimen that includes 2 other ARVs with no
             regimen change for 8 weeks prior to study screening

          -  HIV viral load of 1000 copies/ml or more

          -  Hepatitis B surface antigen negative within 90 days of study entry

          -  Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study
             intervention

          -  Willing to use acceptable forms of contraception

          -  Parent or legal guardian willing to provide consent, if applicable

          -  CD4 count result from a specimen drawn within 120 days prior to study entry

          -  If any previous HIV-1 viral co-receptor tropism result is available, then most recent
             specimen date and the tropism result of that specimen AND specimen date and tropism
             result of any test with either X4 or D/M result, if different from the first specimen,
             must be available

        Inclusion Criteria continued:

          -  Receipt of successful phenotype/genotype resistance results within 105 days prior to
             study treatment intervention assignment

          -  Study team identification of a study regimen and at least 2 NRTIs for participant to
             take

          -  Certain abnormal laboratory values. More information on this criterion can be found in
             the protocol.

        Exclusion Criteria:

          -  Chronic, active hepatitis B virus infection (hepatitis B surface antigen positive or
             HBV DNA positive)

          -  Taking certain medications. More information on this criterion can be found in the
             protocol.

          -  Known allergy/sensitivity to components of two or more of the study-provided drugs or
             their formulations. For maraviroc, this includes hypersensitivity or history of
             allergy to soy lecithin or peanuts.

          -  Active drug or alcohol use that, in the opinion of the investigator, may interfere
             with the study

          -  Pregnancy or breastfeeding

          -  Use of any immunomodulator (interferons, interleukins, systemic corticosteroids, or
             cyclosporine), vaccine, or investigational therapy within 30 days prior to study
             treatment allocation/assignment

          -  Require certain medications prohibited with study treatment

          -  Serious illness requiring systemic treatment or hospitalization. Participants who
             complete therapy or are clinically stable on therapy for at least 14 days prior to
             study treatment allocation are not excluded.