Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00027040
  4. Details
NCT00027040 Clinical Trial

A Study of Decreased Mental Function Associated With HIV

HIV Infections Clinical Trial

Official title:
HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00027040
Other study ID # A5114s
Secondary ID AACTG A5114sACTG
Status Completed
Phase N/A
First received November 16, 2001
Last updated January 15, 2015
Est. completion date June 2005

Study information
Verified date October 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare pictures of the brain of HIV-infected people with memory problems before and after treatment with selegiline. Selegiline is the study drug received through A5090.

HIV patients generally develop memory problems late in the disease. This will be examined using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug selegiline on memory problems also will be examined.

Description:

HIV-associated cognitive impairment generally develops during the later stages of the disease. This study proposes to non-invasively examine the pattern and extent of cerebral injury associated with HIV infection and its response to selegiline by using 1H-MRS. The following hypotheses will be tested: selegiline, a compound with antioxidant and anti-apoptotic properties, will reverse the metabolic abnormalities measured by 1H-MRS, and these changes will parallel the degree of improvement in cognitive and functional performance.

This is a substudy of ACTG A5090. The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS. 1H-MRS evaluations are performed at screening and Week 24 (or at the time of premature discontinuation) of Step 1 of A5090. The screening MRS exams may only be performed once all A5090 screening evaluations (including the lumbar puncture) have been completed and it has been determined that the patient is eligible for A5090 study entry.

The screening MRS must be performed prior to A5090 study drug administration. The Week-24 MRS must be performed while the patient is still on blinded study drug.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are enrolled in ACTG protocol A5090.

- Meet the inclusion/exclusion criteria set forth for the Step 1 phase of AACTG protocol A5090.

Exclusion Criteria

Patients will not be eligible for this study if they have:

- Claustrophobia (unless sedation with lorazepam or zolpidem allows for safe performance of the MRS).

- Metallic implants/medical devices (e.g., skull implants or cardiac devices).

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Selegiline hydrochloride

Locations
Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States UCLA CARE Ctr Los Angeles California
United States Columbia Presbyterian Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Univ of Pennsylvania Philadelphia Pennsylvania
United States Rhode Island Hosp Providence Rhode Island
United States Stanley Street Treatment and Resource Providence Rhode Island
United States The Miriam Hosp Providence Rhode Island
United States Univ of Rochester Medical Center Rochester New York
United States Univ of California, San Diego San Diego California
United States Univ of Washington Seattle Washington
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schifitto G, Yiannoutsos CT, Ernst T, Navia BA, Nath A, Sacktor N, Anderson C, Marra CM, Clifford DB; ACTG 5114 Team. Selegiline and oxidative stress in HIV-associated cognitive impairment. Neurology. 2009 Dec 8;73(23):1975-81. doi: 10.1212/WNL.0b013e3181 — View Citation

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2

External Links