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| ID | Type | Description | Link |
|---|---|---|---|
| NV15355 |
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To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saquinavir | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug | |||
| Zidovudine | Drug | |||
| Zalcitabine | Drug | |||
| Didanosine | Drug |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Body Positive | Phoenix | Arizona | 85016 | United States | ||
| UCLA AIDS Clinical Research Ctr / Dept of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11364377 | Background | Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. | |
| 9708399 | Background | Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001. |
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| Los Angeles |
| California |
| 90024 |
| United States |
| AIDS Research Ctr | Palo Alto | California | 94304 | United States |
| UCD Med Ctr | Sacramento | California | 95817 | United States |
| UCSD Treatment Ctr | San Diego | California | 921036329 | United States |
| Mount Zion Hosp of UCSF | San Francisco | California | 94115 | United States |
| San Francisco Veterans Adm Med Cntr | San Francisco | California | 94121 | United States |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| Miami Veterans Administration Med Ctr | Miami | Florida | 33125 | United States |
| Saint Joseph's Hosp | Tampa | Florida | 33614 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Cook County Hosp | Chicago | Illinois | 60612 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| Tulane Univ / Tulane / LSU Clinical Trials Unit | New Orleans | Louisiana | 70122 | United States |
| New England Med Ctr | Boston | Massachusetts | 02111 | United States |
| Harvard Univ / Massachusetts Gen Hosp | Boston | Massachusetts | 02114 | United States |
| Beth Israel Med Ctr | New York | New York | 10003 | United States |
| St Vincents Hosp and Med Ctr / AIDS Cntr Progrm | New York | New York | 10011 | United States |
| Univ of Oklahoma | Oklahoma City | Oklahoma | 73117 | United States |
| Univ of Pennsylvania / Division of Infectious Disease | Philadelphia | Pennsylvania | 19104 | United States |
| Univ of Texas Med Branch | Galveston | Texas | 775550835 | United States |
| Infectious Diseases Association of Houston | Houston | Texas | 77030 | United States |
| Southern Alberta HIV Clinic / Foot Hills Hosp | Calgary | Alberta | Canada |
| Saint Paul's Hosp / Canadian HIV Trials Network | Vancouver | British Columbia | Canada |
| McMaster Univ Med Ctr | Hamilton | Ontario | Canada |
| Montreal Gen Hosp / Div of Clin Immuno and Allergy | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D019258 | Saquinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| D015215 | Zidovudine |
| D016047 | Zalcitabine |
| D016049 | Didanosine |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| 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 |
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