An Extension of Protocol PRO 140_CD01 Study
NCT02355184 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-10-07
Summary
This is an extension of Protocol PRO 140\_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody) monotherapy in adult subjects with HIV-1 infection
Conditions
- HIV
- Human Immunodeficiency Virus
Interventions
- DRUG
-
PRO 140 350mg weekly subcutaneous (SC) injection.
CCR5 Antagonist
Sponsors & Collaborators
-
CytoDyn, Inc.
lead INDUSTRY
Principal Investigators
-
Jacob Lalezari, MD · CytoDyn, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-18
- Primary Completion
- 2022-06-30
- Completion
- 2022-07-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects
NCT00529243 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT01440569 ·Status: COMPLETED ·Phase: PHASE3
-
Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140
NCT00123890 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
NCT02269917 ·Status: COMPLETED ·Phase: PHASE3
-
D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
NCT01565850 ·Status: COMPLETED ·Phase: PHASE2
-
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
NCT00980538 ·Status: COMPLETED ·Phase: PHASE3
-
Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir
NCT00976404 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
NCT01286740 ·Status: COMPLETED ·Phase: PHASE2
-
Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery
NCT00562510 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05917509 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
NCT01245101 ·Status: TERMINATED ·Phase: PHASE4
-
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
NCT01266902 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
NCT02218320 ·Status: COMPLETED
-
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
NCT01968551 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load
NCT00454337 ·Status: COMPLETED ·Phase: PHASE3
-
Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
NCT01900080 ·Status: UNKNOWN ·Phase: NA
-
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
NCT03405935 ·Status: COMPLETED ·Phase: PHASE3
-
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
NCT00460746 ·Status: COMPLETED ·Phase: PHASE3
-
DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
NCT06034938 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
NCT00504452 ·Status: TERMINATED ·Phase: PHASE2
-
Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment
NCT01363011 ·Status: COMPLETED ·Phase: PHASE3
-
Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
NCT02121795 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients
NCT01475838 ·Status: COMPLETED ·Phase: PHASE3
-
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals
NCT01293123 ·Status: TERMINATED ·Phase: NA
-
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
NCT03227861 ·Status: COMPLETED ·Phase: PHASE3