HIV-1 infection Infections and Infestations HIV-1 infection
Conditions
Interventions
Participants were randomly allocated to the following four groups (three intervention and one control groups):
Intervention - PRO 140, 10 mg/mL solution for intravenous injection:
Sponsors
Progenics Pharmaceuticals, Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, at least age 18 years 2. Screening plasma HIV-1 RNA at least 5,000 copies/mL 3. CD4+ count at least 250 cells/mm3 and no documented count equal to or below 200 cells/mm3 4. Subject has not taken any antiretroviral therapy within three months of the screening visit 5. CCR5-tropic virus based on viral tropism assessment at screening visit 6. Normal resting 12-lead electrocardiogram at screening visit 7. Females of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result recorded within 72 hours prior to the first dose of study drug, and be non-lactating
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant or lactating 2. CXCR4-tropic virus or dual-tropic (R5X4) virus based on the Trofile™ assay at the screening visit 3. Previous participation in an experimental drug trial(s) within 30 days of the screening visit 4. History of hepatitis within the previous six months 5. Any prior treatment with any entry, attachment, co-receptor, or fusion inhibitor, investigational or approved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the tolerability of a single, intravenous dose of PRO 140 within 59 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effect on viral load of ascending single doses of PRO 140 within 59 days 2. To determine the pharmacokinetics of PRO 140 within 59 days | — |
Countries
United States of America
Outcome results
None listed