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Effects of Anti-HIV Therapy on Nervous System Function

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ClinicalTrials.gov Identifier: NCT00432003
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.

Condition or disease
HIV Infections

Detailed Description:

AIDS dementia complex (ADC) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. A milder form of ADC, called HIV minor cognitive/motor disorder (MCMD), is characterized by similar symptoms but has less of an impact on daily functioning. The neurocognitive impairment that results from ADC and MCMD carries an increased risk of poor drug adherence, morbidity, and mortality. It is unclear if highly active antiretroviral therapy (HAART) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. Distal symmetric sensory polyneuropathy (DSPN) and nucleoside-related neuropathy are two other serious conditions that HIV patients are at high risk for. DSPN is thought to be caused by active HIV infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. These 2 conditions may lead to severe pain and discomfort in the feet. It is unknown what connection, if any, there is between DSPN and nucleoside-related neuropathy and the use of HAART. More data are needed on the natural history of these conditions.

This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. The purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. Within 45 days prior to randomization into the main SMART study, participants will have baseline data collected for this substudy. This data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. At selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. At 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. Participants will be followed until the SMART study ends.


Study Design

Study Type : Observational
Actual Enrollment : 297 participants
Time Perspective: Prospective
Official Title: Neurology: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART) to Determine the Impact of the Strategies Upon Central and Peripheral Nervous System Function
Study Start Date : March 2005
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Change in QNPZ-5 scores
  2. time to development of symptomatic peripheral neuropathy
  3. change in peripheral neuropathy symptoms

Secondary Outcome Measures :
  1. Time to neurocognitive impairment
  2. time to development of ADC, stage 2 or greater
  3. chage in peripheral neuropathy symptoms
  4. time to development of asymptomatic or symptomatic peripheral neuropathy
  5. time to resolution of symptomatic peripheral neuropathy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432003


  Show 45 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Edwina Wright, MBBS, FRACP Infectious Disease Unit, the Alfred Hospital
More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00432003     History of Changes
Other Study ID Numbers: CPCRA 065F
CPCRA 065F1
CPCRA 065
10115 ( Registry Identifier: DAIDS-ES )
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
HIV
Antiretroviral Therapy, Highly Active

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases