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NCT Number: NCT00672932

Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

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 to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ucsf Ccrc, Sfgh

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

raltegravir

Drug

400 mg two times daily for three months

Other names: Isentress

Primary outcomes

  1. Change in CSF Concentrations of Neopterin After 12 Weeks

    Time frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)

    CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline.

Secondary outcomes

  1. Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR

    Time frame: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)

    Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pilot Study of Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 6, 2008
Registry last updated
Jul 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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