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| ID | Type | Description | Link |
|---|---|---|---|
| NZTA 4006 |
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The purpose of this study is to see if an HIV-education course can help under-represented, HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level of HIV in the blood, and health status.
Following initial screening, eligible patients are treated with open-label Combivir plus abacavir for 24 weeks. Patients are randomized to undergo the education intervention, Tools for Health and Empowerment (T.H.E.) course plus counseling, or routine counseling only (control group). Measurements and evaluations for assessment of immunologic effects, adherence, and health outcomes are performed at entry (Day 1) and at Weeks 2, 5, 8, 12, 16, and 24.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine/Zidovudine | Drug | |||
| Abacavir sulfate | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Treatment:
Excluded:
Treatment with foscarnet or other agents with required documented activity against HIV-1 in vitro.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy or cytotoxic chemotherapeutic agents received within 4 weeks prior to entry.
Risk Behavior:
Excluded:
Current alcohol or illicit drug use which may interfere with the ability to comply with dosing schedule and protocol evaluation and assessment.
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| Name | Affiliation | Role |
|---|---|---|
| K Rawlings | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIDS Healthcare Foundation | Los Angeles | California | 90027 | United States | ||
| Oasis Clinic / King Drew Med Ctr |
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| Los Angeles |
| California |
| 90059 |
| United States |
| Robert Scott MD | Oakland | California | 94609 | United States |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | United States |
| Whitman Walker Clinic/Elizabeth Taylor Med Ctr | Washington D.C. | District of Columbia | 20009 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Specialty Med Care Ctrs of South Florida Inc | Miami | Florida | 33142 | United States |
| Saint Josephs Comprehensive Research Institute | Tampa | Florida | 33607 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Rush Med College / Dept of Infectious Diseases | Chicago | Illinois | 60612 | United States |
| Encounter Med Group | Oak Park | Illinois | 60301 | United States |
| New England Med Ctr / Div of Geo Med & Infect Disease | Boston | Massachusetts | 02111 | United States |
| Jeffrey Bomser Clinic / NJCR | Newark | New Jersey | 07103 | United States |
| UMDNJ / Dept of Ob/Gyn | Newark | New Jersey | 07103 | United States |
| Newark Community Health Ctr | Newark | New Jersey | 07114 | United States |
| Addiction Research and Treatment Corp | Brooklyn | New York | 11201 | United States |
| Bentley-Salick Med Practice | New York | New York | 10011 | United States |
| Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati | Ohio | 452670405 | United States |
| Allegheny Univ of the Hlth Sciences / Div of Infect Diseases | Philadelphia | Pennsylvania | 19102 | United States |
| Carolina Family Care/Denmark Med Ctr / P O Box 278 | Denmark | South Carolina | 29042 | United States |
| Univ of Tennessee | Memphis | Tennessee | 38103 | United States |
| Univ of Tennessee / Div of Infect Dis / Dept of Med | Memphis | Tennessee | 38165 | United States |
| Southeast Dallas Health Ctr | Dallas | Texas | 75217 | United States |
| Therapeutic Concepts | Houston | Texas | 77004 | United States |
| Santa Rosa Med Ctr / Baptist Med Ctr | San Antonio | Texas | 78205 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D010349 | Patient Compliance |
| 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 |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
| C106538 | abacavir |
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