Clinical trial NCT02990858: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Official title: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hiv
Human Immunodeficiency Virus
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an extension study, to provide continued access to PRO 140 to subjects who complete participation in PRO140_CD02 and continue to receive clinical benefit and would require PRO 140 to form a viable regimen, in the opinion of the treating physician. The patient population for this trial are treatment-experienced HIV infected patients with CCR5-tropic virus who demonstrate evidence of HIV-1 suppression after successfully completed 24 weeks of treatment in the PRO140_CD02 study.


Eligibility criteria: Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study.

1. Subjects who have completed 24 weeks of treatment in PRO 140_CD 02 study, and Investigator believes subject requires continued access to PRO 140 in order to continue deriving clinical benefit and maintain HIV-1 viral suppression
2. HIV-1 RNA ≤ 50 copies/ml at T23 Visit in PRO140_CD02 study
3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], and intrauterine devices) during the course of the study (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.
4. 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: Potential subjects meeting any of the following criteria will be excluded from enrollment.

1. Not currently enrolled in PRO 140_CD 02 study
2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
4. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety measures

Primary outcomes:
measure: Mean change in viral load (HIV-1 RNA levels) at the conclusion of treatment period
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
measure: Mean change in CD4 cell count at the conclusion of treatment period
timeFrame: through study completion, an average of 4 year
measure: Emergence of Dual/Mixed (D/M)- and CXCR4-tropic virus in patients who had exclusive CCR5- tropic virus at study entry.
timeFrame: through study completion, an average of 4 year
measure: Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions
timeFrame: through study completion, an average of 4 year
measure: Frequency of treatment-related adverse events resulting in study drug discontinuation
timeFrame: through study completion, an average of 4 year
measure: Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale
timeFrame: through study completion, an average of 4 year
measure: Frequency of treatment-emergent serious adverse events
timeFrame: through study completion, an average of 4 year
Other outcomes:
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