An Extension of Protocol PRO 140_CD01 TS Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | November 2014 |
| End Date: | September 2020 |
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
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.
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.
Inclusion Criteria:
1. Subjects who have completed 12 weeks of treatment in PRO 140_CD01 study without
experiencing virologic failure.
2. 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.
3. 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:
1. Not currently enrolled in PRO140_CD01 Treatment Substitution Study
2. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993
Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
3. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
4. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant
during the study
5. Unexplained temperature >38.5C (101.3F) for seven consecutive days within 14 days
prior to the first study dose
6. 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
7. Any other clinical condition that, in the Investigator's judgment, would potentially
compromise study compliance or the ability to evaluate safety/efficacy
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