Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10978 | Registry Identifier | DAIDS ES Registry Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zidovudine | Drug |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with active opportunistic infections will be excluded.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Prior Treatment:
Excluded within 30 days of study entry:
Required:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fischl M | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | United States | ||
| UCLA CARE Ctr |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fischl M, Parker CB, Pettinelli C, Wulfsohn M, Rasheed S. The efficacy and safety of a lower dose of zidovudine in the treatment of patients with AIDS-associated PCP. Int Conf AIDS. 1990 Jun 20-23;6(1):138 (abstract no ThB20) | ||
| 8095980 | Background | De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr (1988). 1993 Apr;6(4):359-65. | |
| 1863401 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095 |
| United States |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | United States |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco | California | 941102859 | United States |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | United States |
| Stanford Univ School of Medicine | Stanford | California | 94305 | United States |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | United States |
| Charity Hosp / Tulane Univ Med School | New Orleans | Louisiana | 70112 | United States |
| Louisiana State Univ Med Ctr / Tulane Med School | New Orleans | Louisiana | 70112 | United States |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | United States |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | United States |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | United States |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York | 11373 | United States |
| Beth Israel Med Ctr / Peter Krueger Clinic | New York | New York | 10003 | United States |
| Mem Sloan - Kettering Cancer Ctr | New York | New York | 10021 | United States |
| Mount Sinai Med Ctr | New York | New York | 10029 | United States |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | United States |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | United States |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | United States |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | United States |
| Montefiore Med Ctr / Bronx Municipal Hosp | The Bronx | New York | 10467 | United States |
| Bronx Veterans Administration / Mount Sinai Hosp | The Bronx | New York | 10468 | United States |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | United States |
| Univ of Pittsburgh Med School | Pittsburgh | Pennsylvania | United States |
| Univ of Washington | Seattle | Washington | 98105 | United States |
| Background |
| McMahon DK, Winkelstein A, Armstrong JA, Pazin GJ, Hawk H, Ho M. Zidovudine therapy is associated with an increased capacity of phytohemagglutinin-stimulated cells to express interleukin-2 receptors. Pittsburgh AIDS Clinical Trial Unit. AIDS. 1991 May;5(5):491-6. doi: 10.1097/00002030-199105000-00003. |
| 2114476 | Background | Richman DD, Grimes JM, Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1990;3(8):743-6. |
| Background | Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419) |
| 1680135 | Background | Rinaldo C, Huang XL, Piazza P, Armstrong J, Rappocciolo G, Pazin G, McMahon D, Gupta P, Fan Z, Zhang Z, et al. Augmentation of cellular immune function during the early phase of zidovudine treatment of AIDS patients. J Infect Dis. 1991 Oct;164(4):638-45. doi: 10.1093/infdis/164.4.638. |
| 1977079 | Background | Fischl MA, Parker CB, Pettinelli C, Wulfsohn M, Hirsch MS, Collier AC, Antoniskis D, Ho M, Richman DD, Fuchs E, et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1990 Oct 11;323(15):1009-14. doi: 10.1056/NEJM199010113231501. |
| 2350441 | Background | Unadkat JD, Collier AC, Crosby SS, Cummings D, Opheim KE, Corey L. Pharmacokinetics of oral zidovudine (azidothymidine) in patients with AIDS when administered with and without a high-fat meal. AIDS. 1990 Mar;4(3):229-32. doi: 10.1097/00002030-199003000-00008. |
| 2511447 | Background | Coombs RW, Collier AC, Allain JP, Nikora B, Leuther M, Gjerset GF, Corey L. Plasma viremia in human immunodeficiency virus infection. N Engl J Med. 1989 Dec 14;321(24):1626-31. doi: 10.1056/NEJM198912143212402. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D017088 | AIDS-Related Opportunistic Infections |
| D011020 | Pneumonia, Pneumocystis |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D009894 | Opportunistic Infections |
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D016720 | Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015224 | Dideoxynucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided