Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AI454-148 |
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 compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir mesylate | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug | |||
| Zidovudine | Drug | |||
| Didanosine | Drug |
Inclusion Criteria
Patients must have:
Within 15 business days prior to randomization:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Concurrent Treatment:
Excluded:
Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
Patients with the following prior conditions are excluded:
History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
Prior Treatment:
Excluded:
Therapy for any previous disease that may interfere with patient ability to participate in this study.
Risk Behavior:
Excluded:
Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorra Research Ctr / Med Forum | Birmingham | Alabama | 35203 | United States | ||
| Body Positive |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Hill Top Research Inc | Fresno | California | 93710 | United States |
| UCLA Med Ctr / CARE BH-412 CHS | Los Angeles | California | 90024 | United States |
| AIDS Healthcare Foundation | Los Angeles | California | 900276069 | United States |
| West Los Angeles VAMC | Los Angeles | California | 90073 | United States |
| Sherman Oaks Hosp Research Institute | Sherman Oaks | California | 91403 | United States |
| Harbor UCLA Med Ctr / Research and Educational Institute | Torrance | California | 90502 | United States |
| Yale New Haven Hosp / Nathan Smith Clinic | New Haven | Connecticut | 06504 | United States |
| GW Med Ctr / Clinical Trials Unit | Washington D.C. | District of Columbia | 20037 | United States |
| Med Alternatives | Fort Lauderdale | Florida | 33308 | United States |
| Urgent Care Ctr | Fort Lauderdale | Florida | 33316 | United States |
| Specialty Med Care Ctrs of South Florida Inc | Miami | Florida | 33142 | United States |
| Hillsborough County Health Dept | Tampa | Florida | 33602 | United States |
| Saint Josephs Hosp | Tampa | Florida | 33602 | United States |
| Northwestern Univ / Div of Infect Diseases | Chicago | Illinois | 60611 | United States |
| Rush Presbyterian / ST Lukes Med Ctr | Chicago | Illinois | 60612 | United States |
| Univ of Kansas School of Medicine / Office of Rsch | Wichita | Kansas | 67214 | United States |
| Ky Clinic Annex #4 / Room 205E / Speed Sort #0284 | Lexington | Kentucky | 405360226 | United States |
| Dartmouth-Hitchcock Med Ctr | Lebanon | New Hampshire | 03756 | United States |
| NJCRI | Newark | New Jersey | 07103 | United States |
| Infectious Disease Assoc of Central Jersey | Somerville | New Jersey | 08876 | United States |
| UCT International | Farmingdale | New York | 11735 | United States |
| St Luke Roosevelt Hosp | New York | New York | 10011 | United States |
| St Mary's Hosp (Univ of Rochester/Infectious Diseases) | Rochester | New York | 14642 | United States |
| SUNY at Stony Brook / Div of Infectious Disease | Stony Brook | New York | 117948153 | United States |
| Nalle Clinic / Clinical Research Dept | Charlotte | North Carolina | 28207 | United States |
| Associates in Med and Mental Health | Tulsa | Oklahoma | 74114 | United States |
| Stephen P Hauptman | Philadelphia | Pennsylvania | 19107 | United States |
| Med Univ of South Carolina / Div of Infect Disease | Charleston | South Carolina | 29425 | United States |
| Univ of Texas / Med Branch at Galveston | Galveston | Texas | 775550835 | United States |
| Joseph C Gathe | Houston | Texas | 77004 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| D015215 | Zidovudine |
| D016049 | Didanosine |
| 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 |
| D013936 | Thymidine |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D012263 | Ribonucleosides |
Not provided
Not provided