Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

Stopped early · Not applicable

Conditions studied: HIV

In brief

The primary aim of this study is to determine the effects of the HIV integrase inhibitor, raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before and after initiation of either raltegravir or another antiretroviral, efavirenz, each in combination with two other antiretrovirals. Assessments will include HIV RNA levels (viral load), neuropsychological testing, mood assessments, and quality of life assessments.

Key facts

Study ID

NCT01293123

Run by

University of California, San Diego

People needed

2

Starts

2011-12-01

Expected to finish

2013-12-01

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18-65 years;
• Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
• Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
• Absolute T-cell CD4+ subset between 200-500/mm3
• Individual willing to undergo serial lumbar punctures as outlined in study evaluations;
• Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);
• Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

You may not qualify if…

• Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
• Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
• Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
• Use of prescribed drugs with known substantial interactions with the study drugs;
• Positive HCV serology;
• HIV-associated dementia/Global Deterioration Scale ≥4;
• Pregnancy;
• Serum creatinine higher than 2.0 mg/dL;
• Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal

Where it is running

• UCSD Antiviral Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.