PRO 140 for Human Immunodeficiency Virus
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2014 |
| End Date: | March 2016 |
A Phase 2b, Randomized, Double-blind, Placebo-controlled Clinical Trial of Observed Systemic, Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Recreational Drug Users With Viral Rebound and Poor Adherence to the Previous Antiretroviral Regimen
PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial
of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO
140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected
injection drug users with viral rebound and documented poor adherence to the previous
antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to
receive an optimized background antiretroviral regimen (OBR) plus supervised weekly
subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy
variables will be obtained over the 24 week duration of the study. Safety will be monitored
throughout the course of the study.
of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO
140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected
injection drug users with viral rebound and documented poor adherence to the previous
antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to
receive an optimized background antiretroviral regimen (OBR) plus supervised weekly
subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy
variables will be obtained over the 24 week duration of the study. Safety will be monitored
throughout the course of the study.
Inclusion Criteria:
1. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced
Sensitivity Trofile™ HIV Tropism Assay
2. Males and females, age ≥ 18 years
3. Screening plasma HIV-1 RNA > 1,000 copies/mL confirmed by second test while on the
current antiretroviral regimen
4. History of non-prescription injection and/or non-injection recreational drug use
5. CD4 lymphocyte cell counts > 100 cells/mm3
6. Clinically normal resting 12-lead ECG at screening visit
7. Women of reproductive potential must have a negative serum pregnancy test at Late
Screening Visit. Within hours prior to receiving the first dose of study drug, women
of reproductive potential must have a negative urine pregnancy test. Male and female
subjects must agree not to participate in a conception process and agree to use one
barrier method of contraception plus one other highly reliable contraceptive method
from the early screening visit through week 24.
8. Non-adherent, history of poor adherence to a previous antiretroviral regimen.
Exclusion Criteria:
1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced
Sensitivity Trofile™ HIV Tropism Assay
2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant
during the study
3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A
or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
4. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including
PRO 140, experimental or approved
5. Participation in an experimental drug trial(s) within 30 days of the early screening
visit or during the study
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