Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

NCT01293123 | Terminated Results DMC

• 1 other identifier: 11-0067
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Keywords

HIV; raltegravir; cerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

• Cerebrospinal Fluid HIV RNA Levels

  Slope of decline of HIV RNA levels in CSF over time

  180 days

Secondary Outcomes (4)

• Neuropsychological Performance

  180 days

• Measure of Mood

  180 days

• Measure of Sleep

  180 days

• Measure of Quality of Life

  180 days

Study Arms (2)

Raltegravir

EXPERIMENTAL

Drug: Raltegravir

Efavirenz

ACTIVE COMPARATOR

Drug: Efavirenz

Interventions

Raltegravir DRUG

raltegravir 400 mg PO twice daily

Also known as: tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once daily

Raltegravir

Efavirenz DRUG

efavirenz 600 mg PO once daily

Also known as: tenofovir disoproxil fumarate 300 mg PO once daily, emtricitabine 200 mg PO once daily

Efavirenz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

MeSH Terms

Interventions

Raltegravir Potassium; Tenofovir; Emtricitabine; efavirenz

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Insufficient enrollment for data analysis

Results Point of Contact

• Title: Scott Letendre, Principal Investigator
• Organization: University of California, San Diego

sletendre@ucsd.edu

6195438080

Study Officials

• Scott Letendre, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Locations

US (1)