Safety of AMD070 When Administered Alone or Boosted With Low-Dose Ritonavir in HIV Uninfected Men
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has
      entered cells. AMD070 (also known as AMD11070) is designed to block HIV from entering cells
      and may be effective in treating patients who have developed resistance to or are unable to
      take other anti-HIV drugs. This study will evaluate the safety of different doses of AMD070
      along with AMD070 boosted with ritonavir (RTV) in HIV uninfected men.
    

Detailed description: 
      Current therapy for HIV infection primarily uses drugs that inhibit HIV replication via
      inhibition of viral protease and reverse transcriptase. Many patients either do not tolerate
      these medications well or develop virologic failure due to incomplete viral suppression and
      development of antiviral resistance. New drugs target HIV entry into the cell. AMD070 binds
      to the chemokine receptor CXCR4, inhibiting membrane fusion and viral entry. Animal studies
      have shown AMD070 to be generally safe and well tolerated. The dose-escalation and drug-drug
      interaction study will evaluate the safety, tolerability, and pharmacokinetics of single,
      multiple, and RTV-boosted doses of AMD070 in healthy, HIV uninfected male volunteers.

      Participants in this study will be assigned to a single- or multiple-dose AMD070 group (Group
      1), a single-dose AMD070 group (Group 2), or an RTV-boosted, multiple-dose AMD070 group
      (Group 3). Some participants in Group 1 will be given AMD070 once on an empty stomach with no
      food or drink except for water for 2 hours before and 1 hour after receiving the drug. Up to
      4 different doses will be tested in subgroups of Group 1 participants. Some participants in
      Group 1 will be given AMD070 7 times, 12 hours apart, after eating a standardized breakfast
      30 minutes before receiving the drug; 3 different doses will be tested in this group.
      Participants in Group 2 will be given a single dose of AMD070 after eating a standardized
      meal. Participants in Group 3 will be given a morning dose of AMD070 on Days 1, 3, and 17
      after eating a standardized breakfast 30 minutes before receiving the drug, and a morning and
      evening dose of RTV on Days 3 through 18. Group 3 participants may also be asked to enroll in
      an additional study group that will receive a single dose of AMD070 on Days 1 and 3 while
      fasting.

      All participants will be observed as hospital inpatients. Group 1 and 2 participants will
      stay in the hospital for 24 hours; Group 3 participants will stay in the hospital for 4 days.
      All participants will have blood and urine collection throughout their hospital stay. Group 3
      participants selected to join in the additional study group will have blood and urine samples
      collected throughout the 5-day study. These participants will be discharged from the hospital
      on Day 5 and have a follow-up visit around Day 35. All study participants will also undergo
      an ophthalmologic evaluation and questionnaire sometime after receiving AMD070.
    

Intervention name(s): Ritonavir; AMD070
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ritonavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Seronegativity; CXCR4; AMD11070