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| ID | Type | Description | Link |
|---|---|---|---|
| AI454-158 |
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Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).
Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir mesylate | Drug | |||
| Stavudine | Drug | |||
| Didanosine | Drug |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorra Research Ctr / Med Forum | Birmingham | Alabama | 35203 | United States | ||
| AIDS Healthcare Foundation |
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| Los Angeles |
| California |
| 900276069 |
| United States |
| Robert Scott MD | Oakland | California | 94609 | United States |
| Beacon Clinic / Boulder Community Hosp | Boulder | Colorado | 80304 | United States |
| Community Health Care | Fort Lauderdale | Florida | 33306 | United States |
| Immunity Care and Research Inc | Fort Lauderdale | Florida | 33311 | United States |
| HIV Clinical Research Ctr | Fort Lauderdale | Florida | 33316 | United States |
| South Shore Hosp | Miami | Florida | 33139 | United States |
| Saint Josephs Comprehensive Research Institute | Tampa | Florida | 33607 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 303081962 | United States |
| Chicago Ctr for Clinical Research | Chicago | Illinois | 60610 | United States |
| Univ of Kansas School of Medicine | Wichita | Kansas | 672143124 | United States |
| Univ of Nebraska Med Ctr | Omaha | Nebraska | 681985400 | United States |
| Clinical Studies of Las Vegas | Las Vegas | Nevada | 89128 | United States |
| Anderson Clinical Research Inc | Rego Park | New York | 11374 | United States |
| Anderson Clinical Research Inc | Reading | Pennsylvania | 19604 | United States |
| Coastal Carolina Research Ctr | Mt. Pleasant | South Carolina | 29464 | United States |
| Oak Lawn Physicians Group | Dallas | Texas | 75219 | United States |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 752359103 | United States |
| Nicholaos Bellos | Dallas | Texas | 75246 | United States |
| Houston Clinical Research Network / Div of Montrose Clinic | Houston | Texas | 77006 | United States |
| Swedish Med Ctr | Seattle | Washington | 98122 | United States |
| Clinique Medicale du Quartier Latin | Montreal | Quebec | Canada |
| Clinique Medicale L'Actuele | Montreal | Quebec | Canada |
| 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 |
|---|---|
| D019888 | Nelfinavir |
| D018119 | Stavudine |
| D016049 | Didanosine |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007288 | Inosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D012263 | Ribonucleosides |
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