An Extension of Protocol PRO 140_CD01 TS Study
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|ClinicalTrials.gov Identifier: NCT02355184|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : February 2, 2017
This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO140_CD01 Treatment Substitution Study without experiencing virologic failure.
Consenting patients will continue to receive PRO 140 monotherapy for 160 additional weeks. Total treatment duration with PRO 140 will be up to 161 weeks with one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.
|Condition or disease||Intervention/treatment||Phase|
|HIV Human Immunodeficiency Virus||Drug: PRO 140 350mg weekly SQ injection.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extension of Protocol PRO140_CD01 to Evaluate Long-term Suppression of HIV-1 Replication Following Substitution of Stable Combination ART With PRO 140 (Monoclonal CCR5 Antibody) Monotherapy for Additional 160 Weeks in Adult Subjects w/ HIV-1|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: PRO 140
PRO 140 350mg weekly SQ injection.
Drug: PRO 140 350mg weekly SQ injection.
Other Name: PRO 140
- Time to virologic failure after initiating PRO 140 monotherapy. [ Time Frame: 160 weeks ]Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days.
- Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. [ Time Frame: Up to160 weeks ]
- Mean change in viral load (HIV-1 RNA levels) [ Time Frame: Up to 160 weeks ]
- Mean change in CD4 cell count [ Time Frame: Up to 160 weeks ]
- Change in Quality of Life metrics (up to TE107) [ Time Frame: Up to 160 weeks ]
- Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants(using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: Up to 160 weeks ]
- Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: Up to 160 weeks ]
- Frequency of Treatment-emergent serious adverse events [ Time Frame: Up to 160 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355184
|United States, California|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Sandra Win, MD|