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| ID | Type | Description | Link |
|---|---|---|---|
| VA Study 298 |
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Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidovudine | Drug |
Inclusion Criteria
Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with unstable disease characterized by the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 1 month of study entry:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wadsworth Veterans Administration Med Ctr | Los Angeles | California | 90073 | United States | ||
| San Francisco Veterans Administration Med Ctr |
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| 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 |
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| ID | Term |
|---|---|
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| San Francisco |
| California |
| 94121 |
| United States |
| Walter Reed Army Med Ctr | Washington D.C. | District of Columbia | 203075001 | United States |
| Veterans Administration Med Ctr | Washington D.C. | District of Columbia | 20422 | United States |
| Dr Gordon Dickinson | Miami | Florida | 33136 | United States |
| Dr Gigi Diamond / New York Veterans Administration | New York | New York | 10010 | United States |
| Veterans Affairs Med Ctr / Admin Only / Not For Patient Care | Durham | North Carolina | 27705 | United States |
| Houston Veterans Administration Med Ctr | Houston | Texas | 77030 | United States |
| 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 |
| D006571 |
| Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |