ClinicalTrials.gov

History of Changes for Study: NCT02859961
Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
Latest version (submitted January 13, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 4, 2016 None (earliest Version on record)
2 October 5, 2016 Recruitment Status, Study Status and Contacts/Locations
3 December 14, 2016 Recruitment Status, Study Status and Contacts/Locations
4 February 1, 2017 Contacts/Locations and Study Status
5 March 12, 2018 Contacts/Locations and Study Status
6 February 7, 2019 Arms and Interventions, Study Status and Study Design
7 September 28, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 January 13, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02859961
Submitted Date:  August 4, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: PRO 140_CD03
Brief Title: Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection
Official Title: A Phase 2b/3, Multicenter Study to Assess the Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects With CCR5-tropic HIV-1 Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2016
Overall Status: Recruiting
Study Start: July 2016
Primary Completion: December 2017 [Anticipated]
Study Completion: March 2018 [Anticipated]
First Submitted: July 13, 2016
First Submitted that
Met QC Criteria:
August 4, 2016
First Posted: August 9, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 4, 2016
Last Update Posted: August 9, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: CytoDyn, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

This study is a Phase 2b/3, multi-center study designed to evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks following study entry.

Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Detailed Description:

The primary objective is to assess the treatment strategy of using PRO 140 SC as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 monotherapy will be evaluated.

The secondary objective of the trial is to assess the clinical efficacy, safety and tolerability parameters following substitution of combination antiretroviral therapy with weekly PRO 140 monotherapy.

Open or close this module Conditions
Conditions: HIV
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PRO 140 SC injections
PRO 140 350 mg (175 mg/mL) SC injections per week
Drug: PRO 140
PRO 140 350 mg (175 mg/mL) SC injection per week
Other Names:
  • PRO140
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of participants who remain on PRO 140 monotherapy regimen at the end of week 48 without experiencing virologic failure
[ Time Frame: 48 weeks ]

Secondary Outcome Measures:
1. Proportion of participants experiencing virologic failure while on PRO 140 monotherapy regimen
[ Time Frame: 48 weeks ]

2. Time to virologic failure after initiating PRO 140 monotherapy
[ Time Frame: 48 weeks ]

3. Proportion of participants achieving viral suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure.
[ Time Frame: 48 weeks ]

4. Time to achieving viral suppression (HIV-1 RNA < 50 copies/mL) after experiencing virologic failure
[ Time Frame: 48 weeks ]

5. Proportion of participants with viral suppression (HIV-1 RNA < 50 copies/mL) at week 48 from the start of PRO 140 Treatment Phase.
[ Time Frame: 48 weeks ]

6. Measurement of treatment adherence to the PRO 140 monotherapy regimen
[ Time Frame: 48 weeks ]

7. Total time that participants remain off combination ART regimen, defined as the time between start of PRO 140 monotherapy and restart of combination ART Regimen
[ Time Frame: 48 weeks ]

8. Mean change in CD4 cell count, at each visit within the Treatment Phase
[ Time Frame: 48 weeks ]

9. Proportion of participants experiencing emerging resistance exhibited by fold increase in maraviroc and PRO 140 FC between baseline and the time of virologic failure, as a measure of post-baseline phenotypic resistance
[ Time Frame: 48 weeks ]

10. Central Nervous System (CNS) sub-study: Level of HIV-1 RNA in CSF at T1 (prior to first dose of PRO 140), T4, T16 and VF visits
[ Time Frame: 48 weeks ]

11. Central Nervous System (CNS) sub-study: PRO 140 concentration in CSF at T1 (prior to first dose of PRO 140), T4, T16 and VF visits
[ Time Frame: 48 weeks ]

12. Central Nervous System (CNS) sub-study: Relationship between PRO 140 concentration in plasma and CSF
[ Time Frame: 48 weeks ]

13. Central Nervous System (CNS) sub-study: Relationship between PRO 140 concentration in CSF and HIV-1 RNA in CSF
[ Time Frame: 48 weeks ]

14. Genitourinary (GU) sub-study: Level of HIV-1 RNA in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF visits.
[ Time Frame: 48 weeks ]

15. Genitourinary (GU) sub-study: PRO 140 concentration in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF visits.
[ Time Frame: 48 weeks ]

16. Genitourinary (GU) sub-study: Relationship between PRO 140 concentration in plasma and genital secretion
[ Time Frame: 48 weeks ]

17. Genitourinary (GU) sub-study: Relationship between PRO 140 concentration and HIV-1 RNA in genital secretion
[ Time Frame: 48 weeks ]

Other Outcome Measures:
1. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale)
[ Time Frame: 48 weeks ]

2. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by investigator evaluation of injection site reactions.
[ Time Frame: 48 weeks ]

3. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale
[ Time Frame: 48 weeks ]

4. Frequency of Treatment-emergent serious adverse events
[ Time Frame: 48 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Males and females, age ≥18 years
  2. Receiving combination antiretroviral therapy for last 24 weeks
  3. No change in ART within last 4 weeks prior to Screening Visit
  4. Subject has two or more potential alternative approved ART drug options to consider.
  5. Exclusive CCR5-tropic virus at Screening Visit
  6. Plasma HIV-1 RNA < 50 copies/mL at Screening Visit
  7. CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy
  8. CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit
  9. Laboratory values at Screening of:
    1. Absolute neutrophil count (ANC) ≥ 750/mm3
    2. Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female)
    3. Platelets ≥ 75,000 /mm3
    4. Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN)
    5. Serum aspartate transaminase (SGOT/AST) < 5 x ULN
    6. Bilirubin (total) < 2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in the absence of other evidence of significant liver disease
    7. Creatinine ≤ 1.5 x ULN
  10. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  11. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception during the course of the study.
  12. 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. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay
  2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
  3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
  4. Laboratory test values ≥ grade 4 DAIDS laboratory abnormality.
  5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
  6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose
  7. Any vaccination within 2 weeks prior to the first study dose or during the study.
  8. Subjects who have failed on a maraviroc containing regimen.
  9. Subjects weighing < 35kg
  10. History of anaphylaxis to any oral or parenteral drugs
  11. History of Bleeding Disorder or patients on anti-coagulant therapy
  12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit
  13. Any known allergy or antibodies to the study drug or excipients
  14. Treatment with any of the following:
    1. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit
    2. Immunosuppressants within 60 days prior to the screening visit
    3. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days prior to the screening visit
    4. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception:
      • Subjects on inhaled, nasal, or topical steroids will not be excluded
  15. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Open or close this module Contacts/Locations
Central Contact Person: Kush Dhody, MBBS,MS,CCRA
Telephone: 3019562536
Email: kushd@amarexcro.com
Study Officials: Jacob Lalezari
Principal Investigator
Quest Clinical Research
Locations: United States, California
Quest Clinical Research/eStudy
[Recruiting]
San Francisco, California, United States, 94115
Contact:Contact: Ula Kowalczyk 415-353-0800 ula@questclinical.com
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services