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About
This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.
Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.
Full description
The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.
Enrollment
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Inclusion criteria
Exclusion criteria
Not currently enrolled in PRO140_CD03 study.
Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
Subjects weighing < 35kg.
History of anaphylaxis to any oral or parenteral drugs.
History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin).
Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator.
Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Primary purpose
Allocation
Interventional model
Masking
56 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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