Optimizing Treatment for Treatment-Experienced, HIV-Infected People
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Enfuvirtide; Raltegravir; Darunavir; Tipranavir; Etravirine; Maraviroc
Intervention description: 90mg subcutaneously twice daily; 400 mg twice daily; Two 300-mg tablets twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study); Two 250-mg capsules twice daily, given with ritonavir 100mg twice daily (ritonavir not provided by the study); Two 100-mg tablets twice daily; Dosage dependent on regimen in which maraviroc is included
Intervention MeSH terms: Raltegravir Potassium; Maraviroc; Darunavir; Tipranavir; Enfuvirtide; Etravirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 517.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV
      requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a
      problem for many treatment-experienced, HIV-infected people. The purpose of this study was to
      determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new
      anti-HIV drug regimen for the suppression of HIV.
    

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.