Status:
COMPLETED
CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
University of California, Los Angeles
University of Southern California
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
CCTG 590 is a open-label study to evaluate the impact of therapy intensification with Maraviroc (MVC) (a CCR5 inhibitor) to a stable suppressive HIV antiretroviral regimen on the rate of CD4+ T-cell r...
Detailed Description
Blunted CD4+ T-cell responses during viral control may be a consequence of on-going T-cell destruction in the regenerative phase of CD4 recovery from activation-induced apoptosis and/or reduced produc...
Eligibility Criteria
Inclusion
- HIV-1 infection
- All available CD4+ T cell counts within the last 12 months of screening below 350 cells/mm3 (minimum of 3 values obtained \> 30 days apart).
- HIV treatment with a stable (for at least 6 months) antiretroviral regimen consisting of at least 2 NRTIs and either a protease inhibitor boosted with low dose ritonavir or an NNRTI. A stable regimen is defined as no additions or deletions for more than 14 cumulative days.
- Patient considered to be receiving initial HIV regimen (history of medication substitution for toxicity is allowed).
- All available plasma HIV RNA levels within the last 12 months are below the level of detection. Isolated values that are detectable but \< 1000 copies will be allowed as long as the plasma HIV RNA levels before and after this detectable time point are undetectable - The subject should have a minimum of 3 values obtained \> 30 days apart.
- Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Men and women age ≥ 18 years.
Exclusion
- Current antiretroviral regimen contains tenofovir disoproxil fumarate AND didanosine in combination.
- History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
- History of chronic active hepatitis B (defined as surface antibody negative, surface antigen positive and HBV DNA detectable).
- Concurrent use of G-CSF or GM-CSF.
- Prior or concurrent use of IL-2.
- Prior or concurrent use of a CCR5 inhibitor.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
- Use of human growth hormone within 30 days prior to study entry.
- Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).
- Evidence of splenic sequestration or suppressed bone marrow function:
- Clinical or radiographic evidence of significant splenomegaly.
- History of leukemia or lymphoma.
- History of myelosuppressive chemotherapy or irradiation
Key Trial Info
Start Date :
October 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00925756
Start Date
October 20 2008
End Date
April 11 2014
Last Update
August 19 2020
Active Locations (3)
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1
University Southern California
Los Angeles, California, United States, 90033
2
University California San Diego
San Diego, California, United States, 92103
3
Harbor-UCLA
Torrance, California, United States, 90502