An Extension of Protocol PRO 140_CD01 TS Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: PRO 140 350mg weekly SQ injection.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without experiencing virologic failure. Both male and female patients and their partners of childbearing potential must agree to use appropriate birth control methods (birth control pills, barriers, or abstinence) throughout the study duration (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative urine pregnancy test prior to receiving the first dose of study drug. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent. Exclusion Criteria: Not currently enrolled in PRO140_CD01 Treatment Substitution Study Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition Laboratory test values ≥ grade 4 DAIDS laboratory abnormality. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days prior to the first study dose Diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) that in the opinion of the primary care provider and/or site investigator would interfere with the subject's successful completion of the study requirements Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO 140<br>PRO 140 350mg weekly SQ injection. | Drug: PRO 140 350mg weekly SQ injection.<br>* CCR5 Antagonist<br>* Other names: PRO 140;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to virologic failure after initiating PRO 140 monotherapy. | Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. | 160 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants with virologic failure after initiating PRO 140 monotherapy. |  | Up to160 weeks | 
| Mean change in viral load (HIV-1 RNA levels) |  | Up to 160 weeks | 
| Mean change in CD4 cell count |  | Up to 160 weeks | 
| Change in Quality of Life metrics (up to TE107) |  | Up to 160 weeks |