A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naīve Patients Infected With R5-Tropic HIV-1

There are now several HIV treatment options for a person with HIV infection who has not yet been treated. Most people who receive treatment and take their medications as directed have a good result. This is usually determined by measuring the amount of HIV in the blood (viral load). The best response is when HIV cannot be found (less than 50 copies/mL) in the blood. However, it has recently become clear that some people with HIV who are receiving effective HIV drugs continue to have more health problems than people without HIV infection. Sometimes, there is damage to organs in the body, including bone, kidneys, and the brain. The main purpose of this study is to compare the effects on bones of the following two drug combinations: - maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) - tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional reasons this study is being done are the following: - To see how the drug combinations affect the brain and kidneys. - To see how well the drug combinations lower the HIV viral load. - To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs. - To see how well the drug combinations get into the blood.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Tenofovir disoproxil fumarate
  • drug : Placebo for Tenofovir disoproxil fumarate
  • drug : Placebo for Maraviroc
  • drug : emtricitabine
  • drug : darunavir
  • drug : Placebo for Maraviroc
  • drug : Darunavir
  • drug : Ritonavir
  • drug : Tenofovir disoproxil fumarate
  • drug : Emtricitabine
  • drug : Placebo for Tenofovir disoproxil fumarate
  • drug : ritonavir

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- HIV-1 infection - No evidence of exclusionary resistance mutations defined as evidence of any major NRTI mutation according to the current IAS list of HIV-1 Resistance Mutations Associated with Drug Resistance, or any DRV RAMs (refer to the A5303 PSWP for a list of these mutations) on any genotype; or evidence of significant NRTI or DRV resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations are not exclusionary. - ARV drug-naīve, defined as </=10 days of ART at any time prior to study entry, except in the instances defined in section 4.1.3 of the protocol. - R5-only tropism based on Trofile testing performed within 90 days prior to study entry. - Screening HIV-1 RNA >1000 copies/mL obtained within 90 days prior to study entry by any FDA-approved test for quantifying HIV-1 RNA at any laboratory that has a CLIA certification or its equivalent. - Known hepatitis C virus (HCV) antibody status (performed at any laboratory that has a CLIA certification or its equivalent). - Certain laboratory values obtained within 60 days prior to study entry, as defined in section 4.1.7 of the protocol. - For women of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ?25 mIU/mL within 72 hours prior to study entry. - Female subjects of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception (as defined in section 4.1.9.1 of the protocol) while receiving the study drugs and for 6 weeks after stopping the medications. - Female subjects who are not of reproductive potential or whose male partner(s) has azoospermia are eligible to take study drugs without the use of contraceptives. - Ability and willingness of subject or legal guardian/representative to give written informed consent. - Willingness to undergo neuropsychological testing. - DXA scan performed after confirmation of the subject's eligibility by Trofile testing but no more than 4 weeks prior to randomization.

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Contact information

Primary Contact:

Debbie Slamowitz, RN, BSN, ACRN (650) 723-2804

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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