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| ID | Type | Description | Link |
|---|---|---|---|
| CPCRA 065F1 | |||
| CPCRA 065 | |||
| 10115 | Registry Identifier | DAIDS-ES |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in QNPZ-5 scores | ||
| time to development of symptomatic peripheral neuropathy | ||
| change in peripheral neuropathy symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neurocognitive impairment | ||
| time to development of ADC, stage 2 or greater | ||
| chage in peripheral neuropathy symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edwina Wright, MBBS, FRACP | Infectious Disease Unit, the Alfred Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Castro-Mission Health Ctr. CRS | San Francisco | California | 94114 | United States | ||
| Kaiser Permanente of Denver CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15744843 | Background | Antunes F. Central nervous system AIDS--related diseases. Acta Neurochir (Wien). 2004 Oct;146(10):1071-4. doi: 10.1007/s00701-004-0334-0. | |
| 15096404 | Background | Morgello S, Estanislao L, Simpson D, Geraci A, DiRocco A, Gerits P, Ryan E, Yakoushina T, Khan S, Mahboob R, Naseer M, Dorfman D, Sharp V; Manhattan HIV Brain Bank. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol. 2004 Apr;61(4):546-51. doi: 10.1001/archneur.61.4.546. |
| Label | URL |
|---|---|
| Click here for information on CPCRA 065 | View source |
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| time to development of asymptomatic or symptomatic peripheral neuropathy |
| time to resolution of symptomatic peripheral neuropathy |
| Denver |
| Colorado |
| 80204-4507 |
| United States |
| Univ. of Colorado Health Science Ctr. CRS | Denver | Colorado | 80204-4507 | United States |
| Denver Public Health CRS | Denver | Colorado | 80204 | United States |
| Eastside Family Health Ctr. CRS | Denver | Colorado | 80205 | United States |
| Western Infectious Disease Consultants CRS | Wheat Ridge | Colorado | 80033 | United States |
| Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS | Washington D.C. | District of Columbia | 20422 | United States |
| Univ. of Florida, Div. of Infectious Diseases CRS | Jacksonville | Florida | 32206 | United States |
| Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS | Baton Rouge | Louisiana | 70805 | United States |
| Wayne State Univ. CRS | Detroit | Michigan | 48201 | United States |
| Henry Ford Hosp. CRS | Detroit | Michigan | 48202 | United States |
| Michigan State Univ., Infectious Disease Clinic CRS | Lansing | Michigan | 48910 | United States |
| SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS | Brooklyn | New York | 11203 | United States |
| Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) | New York | New York | 10037-1802 | United States |
| Bronx-Lebanon Hosp. Ctr. CRS | The Bronx | New York | 10457 | United States |
| Jacobi Med. Ctr., Ambulatory Care Pavillion CRS | The Bronx | New York | 10461 | United States |
| Montefiore Med. Ctr., AIDS Ctr. CRS | The Bronx | New York | 10467 | United States |
| Bronx VAMC CRS | The Bronx | New York | 10468 | United States |
| Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS | Oklahoma City | Oklahoma | 73104 | United States |
| The Research & Education Group-Portland CRS | Portland | Oregon | 97210 | United States |
| Kaiser Immune Deficiency Clinic of Portland CRS | Portland | Oregon | 97227 | United States |
| Legacy Clinic Emanuel CRS | Portland | Oregon | 97227 | United States |
| Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS | Portland | Oregon | 97239 | United States |
| Temple Univ. School of Medicine CRS | Philadelphia | Pennsylvania | 19140 | United States |
| MediCorp, Infectious Disease Associates CRS | Fredericksburg | Virginia | 22401 | United States |
| Vernon Harris East End Community Health Ctr. CRS | Richmond | Virginia | 23223 | United States |
| CrossOver Health Ctr. CRS | Richmond | Virginia | 23224 | United States |
| VCU Health Systems, Infectious Disease Clinic CRS | Richmond | Virginia | 23298 | United States |
| Virginia Commonwealth Univ. Medical Ctr. CRS | Richmond | Virginia | 23298 | United States |
| Med. College of Wisconsin, Infectious Disease Clinic CRS | Milwaukee | Wisconsin | 53226 | United States |
| Burwood Road Gen. Practice CRS | Burwood | New South Wales | 2134 | Australia |
| St. Vincent's Hospital CRS | Darlinghurst | New South Wales | 2010 | Australia |
| Westmead Hospital CRS | Westmead | New South Wales | 2145 | Australia |
| Melbourne Sexual Health Ctr. CRS | Carlton | Victoria | Australia |
| The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS | Melbourne | Victoria | 3004 | Australia |
| Prahran Market Clinic CRS | Melbourne | Victoria | 3181 | Australia |
| Hosp. Universitario Prof. Edgard SantosCRS | Salvador | Estado de Bahia | 40110-160 | Brazil |
| Instituto de Infectologia Emilio Ribas CRS | São Paulo | 01246-900 | Brazil |
| Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Windsor Regional Hosp., HIV Care Program CRS | Windsor | Ontario | N8W 1E3 | Canada |
| Bamrasnaradura Institute CRS | Muang | Changwat Nonthaburi | Thailand |
| Chulalongkorn University Hospital CRS | Bangkok | Ratchathewi | Thailand |
| Mahidol Univ., Ramathibodi Hosp., Div of Infectious Disease CRS | Bangkok | Ratchathewi | Thailand |
| Sanpatong Hosp. CRS | Chiang Mai | Thailand |
| Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici | Khon Kaen | 40002 | Thailand |
| 12491162 | Background | Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. doi: 10.1080/13550280290101094. |
| 15813646 | Background | Verma S, Estanislao L, Simpson D. HIV-associated neuropathic pain: epidemiology, pathophysiology and management. CNS Drugs. 2005;19(4):325-34. doi: 10.2165/00023210-200519040-00005. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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