Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/16/2016 |
| Start Date: | May 2014 |
| End Date: | September 2016 |
A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability
of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable
on combination antiretroviral therapy.
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140
monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the
one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study
treatment, and one week overlap at the end of the treatment in subjects who do not
experience virologic failure.
of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable
on combination antiretroviral therapy.
Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140
monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the
one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study
treatment, and one week overlap at the end of the treatment in subjects who do not
experience virologic failure.
Inclusion Criteria:
1. Males and females, age ≥18 years
2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
3. On stable antiretroviral therapy for last 12 months
4. Subject has two or more potential alternative antiretroviral regimen options to
consider.
5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12
months prior to Screening Visit
6. Nadir CD4 cell count of >200 cells/mm3
Exclusion Criteria:
1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA
Assay at the Screening Visit
2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen
(HBsAg)
3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993
Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including
PRO 140.
5. Any other clinical condition that, in the Investigator's judgment, would potentially
compromise study compliance or the ability to evaluate safety/efficacy
We found this trial at
1
site
San Francisco, California 94115
Principal Investigator: Jacob Lalezari, MD
Phone: 301-956-2536
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