HIV Clinical Trial
Official title:
A Prospective, Open-Label, Double-Arm, Crossover, Single-Center Pilot Study to Evaluate the Addition of Raltegravir to Established Suppressive Antiretroviral Therapy While Monitoring Changes in Markers of Immune Activation Among HIV-1 Infected Individuals Without Adequate Immune Restoration
Verified date | June 2015 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will examine whether intensification with raltegravir of a suppressive antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial effect on cryptic viral replication and the immune system. Specifically, the investigators will examine the effect that raltegravir intensification of ART has on episomal cDNA frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial translocation.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | October 2015 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: To qualify for this study, participants will need to have: 1. At least 18 years of age 2. Documented HIV-1 infection 3. CD4+ count <350 cells/mm3 at the time of enrollment or CD4+ count increase of <100 cells/mm3 within the past 2 years 4. Plasma viral load <400 copies/ml at all testing time points within the preceding 2 years AND <50 copies/ml by RT-PCR or <75 copies/ml by bDNA at the 2 testing time points immediately preceding enrollment into the study Exclusion Criteria: To qualify for this study, patients must not meet any of the following exclusion criteria: 1. Pregnancy or breast-feeding 2. Prior use of raltegravir at any time in the past 3. Use of any investigational, immunomodulatory, immunosuppressive agents within 90 days prior or during this study 4. Alcohol or substance abuse that in the opinion of the investigator might interfere with patient compliance or safety 5. Any condition or pre-study laboratory abnormality that in the opinion of the investigator might interfere with patient compliance or safety |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Infectious Diseases Research Unit, University of Miami Miller School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Episomal HIV cDNA formation | These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication. | 40 weeks | No |
Secondary | Markers of immune activation | Flow cytometry will be performed in whole blood for analysis of markers CD3, CD4, CD8, HLA-DR and CD38 by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD3+CD4+T cells, and frequencies of CD3+CD8+ subset, CD8+CD38+; CD8+ HLA-DR+ and CD8+HLADR+ CD38+ cells will be determined. | 40 weeks | No |
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