Status:
COMPLETED
Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention...
Eligibility Criteria
Inclusion
- Capacity to provide informed consent.
- Documented HIV-1 infection.
- History of continuous cART treatment (with at least three drugs) for at least 2 years.
- Documentation of 'undetectable' plasma HIV-1 RNA for at least 1 year.
- HIV-1 RNA \<50 copies/mL in plasma and CSF at screening visit.
Exclusion
- Contraindication to LP (suspicion of CNS mass lesion, bleeding diathesis, etc.).
- Prior experience with raltegravir or contraindication to raltegravir treatment, including medication interactions that might compromise ongoing antiretroviral therapy or treatment of other conditions.
- Active opportunistic infections or neurological diseases.
- Other conditions or treatments likely to interfere with treatment or evaluation.
- Hemoglobin \< 10 Gm/dL.
- Pregnant or anticipating pregnancy during study.
- Active substance abuse.
- Subjects taking rifampin, phenytoin, Phenobarbital or other drugs that accelerate raltegravir metabolism and might decrease its tissue concentrations.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00672932
Start Date
April 1 2008
End Date
February 1 2011
Last Update
July 5 2013
Active Locations (1)
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1
Ucsf Ccrc, Sfgh
San Francisco, California, United States, 94110