Safety of AMD070 When Administered Alone or Boosted With Low-Dose Ritonavir in HIV Uninfected Men
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV Seronegativity, CXCR4, AMD11070
Eligibility Criteria
Inclusion Criteria for all participants: HIV uninfected males in good general health Normal electrocardiogram (EKG) and lab values Body weight within 33% of ideal weight for height within 28 days of study entry Willing to refrain from exercise for 24 hours prior to study entry Willing to use acceptable forms of contraception Inclusion Criteria for Group 3's Additional Study: Willing to refrain from consumption of alcohol and grapefruit juice for the duration of the study Exclusion Criteria for all participants: Prescription medications, herbal supplements, or aspirin within 7 days of study entry Nonsteroidal anti-inflammatory drugs, over-the-counter medications, and other supplements (including multivitamins) within 1 day of study entry Active infection or acute illness within 14 days of study entry Drug or alcohol abuse or dependence Known sensitivity to AMD070 History of gastrointestinal bleeding or ulcer Any medical or psychological condition that, in the opinion of the investigator, would interfere with study participation Exclusion Criteria for Group 3: Immunizations within 30 days of study entry Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulating agents within 30 days of study entry Chronic diarrhea for more than 4 weeks prior to study entry Heart conduction abnormalities, heart arrhythmias, cardiomyopathy, any repolarization delay, or other risk factors for heart failure and hypokalemia Exclusion Criteria for Group 3's Additional Study: Grade 3 or 4 adverse event while participating in Group 3 Consumption of alcohol within 48 hours of study entry
Sites / Locations
- Johns Hopkins Adult AIDS CRS
- University of Washington AIDS CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
1
2
3
escalating single doses of AMD070 ranging from 1/4 to 1 times the maximum tolerated dose (MTD)
single dose of 200 mg AMD070 after eating a standardized meal
single dose of 200 mg AMD070 on Days 1, 3, and 17 and single dose of 100 mg ritonavir on Days 3 through 18