| ID | Type | Description | Link |
|---|---|---|---|
| 075-00 |
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The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Efavirenz | Drug | |||
| Levocarnitine | Drug | |||
| Adefovir dipivoxil | Drug |
Inclusion Criteria
Patients must have:
Nelfinavir-Failure Group:
Control Group:
Exclusion Criteria
Prior Medication:
Excluded:
Control group:
Required:
Nelfinavir-failure patients:
Control group:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAC / USC Med Ctr / Infectious Diseases | Los Angeles | California | 90033 | United States | ||
| Yale Univ / AIDS Clinical Trials Unit |
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| New Haven |
| Connecticut |
| 06510 |
| United States |
| Med Ctr of Delaware | Wilmington | Delaware | 19899 | United States |
| Hawaii AIDS Clinical Trial Unit | Honolulu | Hawaii | 96816 | United States |
| Rush Presbyterian Saint Lukes Med Ctr | Chicago | Illinois | 606123832 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 212876220 | United States |
| Massachusetts Gen Hosp | Boston | Massachusetts | 02114 | United States |
| Columbia Presbyterian Hosp | New York | New York | 10032 | United States |
| AIDS TMT Unit / Univ Hosp | Stony Brook | New York | 117948153 | United States |
| Vanderbilt Clinic | Nashville | Tennessee | 37212 | United States |
| Oaklawn Physicians Group | Dallas | Texas | 75219 | 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 |
|---|---|
| D019469 | Indinavir |
| C098320 | efavirenz |
| D002331 | Carnitine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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