A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence
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ClinicalTrials.gov Identifier: NCT01272258 |
Recruitment Status
:
Withdrawn
(Lack of enrollment)
First Posted
: January 7, 2011
Last Update Posted
: February 2, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: PRO 140 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Observed Systemic, Long-Acting, Anti-HIV Treatment With a Monoclonal Anti CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-Infected Injection Drug Users With Viral Rebound and Documented Poor Adherence to the Previous Antiretroviral Regimen |
Study Start Date : | December 2013 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | February 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
PRO 140
|
Drug: PRO 140
SC injection
|
Placebo Comparator: Arm 2
Placebo
|
Drug: Placebo
SC injection
|
- Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24. [ Time Frame: 24 Weeks ]Percentage of subjects without virologic failure at week 24.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Only R5 virus
- HIV-1 RNA > 1,000 copies/mL but < 100,000 copies/mL
- CD4+ lymphocyte counts > 100 cells/μL
- Non-prescription recreational drug use within the previous 6 months
Key Exclusion Criteria:
- Females who are pregnant (positive blood test), lactating, or breastfeeding, or who plan to become pregnant during the study
- Prior use of any CCR5 entry inhibitors
- History of any acquired immune deficiency syndrome (AIDS)-defining illness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272258
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102 |
Responsible Party: | CytoDyn, Inc. |
ClinicalTrials.gov Identifier: | NCT01272258 History of Changes |
Other Study ID Numbers: |
PRO 140 2102 |
First Posted: | January 7, 2011 Key Record Dates |
Last Update Posted: | February 2, 2017 |
Last Verified: | January 2017 |
Additional relevant MeSH terms:
Antibodies HIV Antibodies PRO-140 monoclonal antibody Immunologic Factors Physiological Effects of Drugs HIV Fusion Inhibitors |
Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |