Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AG1549-504 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine/Zidovudine | Drug | |||
| Capravirine | Drug | |||
| Nelfinavir mesylate | Drug |
Inclusion Criteria
Patients may be eligible if they:
Exclusion Criteria
Patients will not be eligible if they:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Ctr Inc | Tucson | Arizona | 85712 | United States | ||
| Univ of Southern California |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90033 |
| United States |
| Highland Gen Hosp / San Francisco Gen Hosp | Oakland | California | 946021018 | United States |
| ViRx Inc | Palm Springs | California | 92262 | United States |
| Research & Treatment at the California Pacific Med Ctr | San Francisco | California | 94114 | United States |
| Harbor - UCLA Med Ctr | Torrance | California | 90502 | United States |
| IDC Research Initiative | Altamonte Springs | Florida | 32701 | United States |
| Bach and Godofsky | Bradenton | Florida | 34205 | United States |
| Community Health Care | Fort Lauderdale | Florida | 33306 | United States |
| Univ of Florida | Jacksonville | Florida | 32209 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 33136 | United States |
| South Shore Hosp | Miami | Florida | 33139 | United States |
| Specialty Med Care Ctrs of South Florida Inc | Miami | Florida | 33142 | United States |
| Orange County Health Dept | Orlando | Florida | 32805 | United States |
| Larry Bush | Palm Springs | Florida | 33461 | United States |
| Infectious Diseases Associates | Sarasota | Florida | 34239 | United States |
| Infectious Disease Research Institute | Tampa | Florida | 33614 | United States |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | United States |
| Polk County Health Dept | Winter Haven | Florida | 33881 | United States |
| Sky Blue | Boise | Idaho | 83704 | United States |
| Northwestern Univ Med Ctr | Chicago | Illinois | 60611 | United States |
| The CORE Ctr | Chicago | Illinois | 60612 | United States |
| Indiana Univ Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | United States |
| Univ of Iowa | Iowa City | Iowa | 52242 | United States |
| Univ of Kansas School of Medicine | Wichita | Kansas | 67214 | United States |
| University of Louisville / ID Division | Louisville | Kentucky | 40202 | United States |
| HIV Outpatient Clinics / LA State Univ Med Ctr | New Orleans | Louisiana | 70112 | United States |
| Fenway Community Health Ctr | Boston | Massachusetts | 02115 | United States |
| Hawthorne Med Associates / PAACA | New Bedford | Massachusetts | 02745 | United States |
| Kansas City AIDS Research Consortium | Kansas City | Missouri | 64111 | United States |
| Univ of Nebraska Medical Ctr | Omaha | Nebraska | 681985400 | United States |
| Paul Alessi | Cherry Hill | New Jersey | 08034 | United States |
| VAMC New Jersey Healthcare System | East Orange | New Jersey | 07018 | United States |
| St Mary's Hosp Family Treatment Ctr | Hoboken | New Jersey | 07030 | United States |
| Univ of Med & Dentistry of New Jersey | Newark | New Jersey | 07103 | United States |
| Bentley-Salick Medical Practice PC | New York | New York | 10003 | United States |
| Univ of Rochester Med Ctr | Rochester | New York | 14642 | United States |
| Univ of Cincinnati / Holmes Hosp | Cincinnati | Ohio | 452670405 | United States |
| Med Univ of South Carolina | Charleston | South Carolina | 29425 | United States |
| Julio Arroyo | West Columbia | South Carolina | 29169 | United States |
| Southwest Infectious Diseases Associates | Dallas | Texas | 75246 | United States |
| Univ TX Galveston Med Branch | Galveston | Texas | 77555 | United States |
| Joseph C Gathe | Houston | Texas | 77004 | United States |
| Thomas Street Clinic | Houston | Texas | 77009 | United States |
| Hampton Roads Med Specialists | Hampton | Virginia | 23666 | United States |
| Wisconsin AIDS Research Consortium | Milwaukee | Wisconsin | 53203 | United States |
| Canadian HIV Trials Network | Vancouver | British Columbia | Canada |
| QEII Health Science Centre | Halifax | Nova Scotia | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | Canada |
| Montreal Chest Institute | Montreal | Quebec | Canada |
| Immunity Care and Research Inc | Santo Domingo | Dominican Republic |
| Univ of Puerto Rico School of Med | Rio Piedras | 00935 | Puerto Rico |
| Clinical Research Puerto Rico Inc | San Juan | 009091711 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D018450 | Disease Progression |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C109078 | lamivudine, zidovudine drug combination |
| C433874 | capravirine |
| D019888 | Nelfinavir |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided