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| ID | Type | Description | Link |
|---|---|---|---|
| APV30001 |
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The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir sulfate | Drug | |||
| Nelfinavir mesylate | Drug | |||
| Lamivudine | Drug | |||
| GW433908 | Drug |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Clinical Trial Ctr | Concord | California | 94520 | United States | ||
| Ocean View Internal Medicine |
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| Long Beach |
| California |
| 90803 |
| United States |
| Florida ID Group | Orlando | Florida | 32801 | United States |
| Hillsborough County Health Dept | Tampa | Florida | 33602 | United States |
| Clinical Pharmacology Services | Tampa | Florida | 33617 | United States |
| Veterans Affairs Med Ctr of North Chicago | Chicago | Illinois | 60064 | United States |
| Univ of Kansas Med Ctr | Kansas City | Kansas | 661607415 | United States |
| Saint Michael's Med Ctr | Newark | New Jersey | 07102 | United States |
| UMDNJ - New Jersey Med School | Newark | New Jersey | 071032757 | United States |
| Addiction Research and Treatment Corp | Brooklyn | New York | 11201 | United States |
| Brookdale Univ Hosp and Med Ctr | Brooklyn | New York | 112123198 | United States |
| Gervais Frechette | New York | New York | 10011 | United States |
| Howard Grossman | New York | New York | 10011 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Univ of Rochester Med Ctr | Rochester | New York | 14642 | United States |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | United States |
| SMO-USA Inc | Charlotte | North Carolina | 28211 | United States |
| Advanced Clinical Trials Inc | Eugene | Oregon | 97401 | United States |
| Thomas Jefferson Univ | Philadelphia | Pennsylvania | 19107 | United States |
| Univ of Texas Med Branch | Galveston | Texas | 775550835 | United States |
| MacGregor Med Association | Houston | Texas | 77054 | United States |
| Walter Gaman | Irving | Texas | 75038 | United States |
| Southwest Texas Methodist Hosp | San Antonio | Texas | 78229 | United States |
| 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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| ID | Term |
|---|---|
| C106538 | abacavir |
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| C426859 | fosamprenavir |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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