Overview

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

Status:
Terminated

Trial end date:
2013-12-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of California, San Diego

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Efavirenz
Emtricitabine
Raltegravir Potassium
Tenofovir

Criteria

Inclusion Criteria:

1. Men and women aged 18-65 years;

2. Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the
supervision of their HIV care provider;

3. Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in
CSF;

4. Absolute T-cell CD4+ subset between 200-500/mm3

5. Individual willing to undergo serial lumbar punctures as outlined in study
evaluations;

6. 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);

7. Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

Exclusion Criteria:

1. Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia
(platelets below 50,000/µL), or use of anticoagulants;

2. Cognitive, psychiatric, or substance use disorders or any other medical conditions
that would interfere with study participation, in the opinion of the investigator;

3. Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;

4. Use of prescribed drugs with known substantial interactions with the study drugs;

5. Positive HCV serology;

6. HIV-associated dementia/Global Deterioration Scale ≥4;

7. Pregnancy;

8. Serum creatinine higher than 2.0 mg/dL;

9. Total bilirubin or alanine or aspartate transaminases more than 3 times the upper
limit of normal