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| ID | Type | Description | Link |
|---|---|---|---|
| 11191 | Registry Identifier | DAIDS ES Registry Number |
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PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
SECONDARY: To determine whether significant advantages to any one vaccine exist.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aluminum hydroxide | Biological | |||
| MF59 | Biological | |||
| rgp120/HIV-1IIIB | Biological | |||
| rgp120/HIV-1MN | Biological | |||
| rgp120/HIV-1 SF-2 | Biological | |||
| Env 2-3 | Biological |
Inclusion Criteria
Concurrent Medication:
Allowed:
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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| Name | Affiliation | Role |
|---|---|---|
| Schooley RT | Study Chair | |
| Walker B | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Center CRS | Los Angeles | California | United States | |||
| Stanford CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756) | ||
| 11023459 | Background | Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9. |
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| Palo Alto |
| California |
| 94115 |
| United States |
| Santa Clara Valley Med. Ctr. | San Jose | California | 951282699 | United States |
| San Mateo County AIDS Program | San Mateo | California | 943055107 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | United States |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | United States |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 981224304 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
|---|---|
| D000536 | Aluminum Hydroxide |
| C089950 | MF59 oil emulsion |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
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