The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
The Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
2 other identifiers
interventional
538
1 country
40
Brief Summary
To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated. In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
- The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be \< 800 cells/mm3, and at least 1 of 2 counts and the mean must be \> 200 cells/mm3). The last count must be within 14 days of study entry.
- Concurrent Medication:
- Allowed:
- Acetaminophen and acetaminophen products but use should be minimized. Continuous use for \> 72 hours is discouraged.
- Aerosolized pentamidine.
- Prior Medication:
- Allowed:
- Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count \< 200 cells/mm3 measured on 2 determinations at least 48 hours apart.
You may not qualify if:
- Concurrent Medication:
- Excluded:
- Other antiretroviral agents, biologic modifiers or corticosteroids.
- Other experimental medications.
- Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.
- Prior Medication:
- Excluded:
- Zidovudine (AZT).
- Other antiretroviral agents.
- Excluded within 30 days of study entry:
- Biologic modifiers or corticosteroids.
- Excluded within 60 days of study entry:
- Ribavirin.
- Prior Treatment:
- Excluded within 30 days of study entry:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, 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
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, 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
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, 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
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, 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 - Stony Brook
Stony Brook, New York, 117948153, 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
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Columbus Children's Hosp
Columbus, Ohio, 432052696, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98105, United States
Related Publications (10)
Fischl MA, Richman DD, Hansen N, Collier AC, Carey JT, Para MF, Hardy WD, Dolin R, Powderly WG, Allan JD, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group. Ann Intern Med. 1990 May 15;112(10):727-37. doi: 10.7326/0003-4819-112-10-727.
PMID: 1970466BACKGROUNDBass HZ, Hardy WD, Mitsuyasu RT, Wang YX, Cumberland W, Fahey JL. Eleven lymphoid phenotypic markers in HIV infection: selective changes induced by zidovudine treatment. J Acquir Immune Defic Syndr (1988). 1992;5(9):890-7.
PMID: 1512689BACKGROUNDBass HZ, Nishanian P, Hardy WD, Mitsuyasu RT, Esmail E, Cumberland W, Fahey JL. Immune changes in HIV-1 infection: significant correlations and differences in serum markers and lymphoid phenotypic antigens. Clin Immunol Immunopathol. 1992 Jul;64(1):63-70. doi: 10.1016/0090-1229(92)90060-2.
PMID: 1376654BACKGROUNDWu AW, Rubin HR, Mathews WC, Brysk LM, Bozzette SA, Hardy WD, Atkinson JH, Grant I, Spector SA, McCutchan JA, et al. Functional status and well-being in a placebo-controlled trial of zidovudine in early symptomatic HIV infection. J Acquir Immune Defic Syndr (1988). 1993 May;6(5):452-8.
PMID: 8483109BACKGROUNDJacobson MA, Gundacker H, Hughes M, Fischl M, Volberding P. Zidovudine side effects as reported by black, Hispanic, and white/non-Hispanic patients with early HIV disease: combined analysis of two multicenter placebo-controlled trials. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Jan 1;11(1):45-52. doi: 10.1097/00042560-199601010-00006.
PMID: 8528732BACKGROUNDKozal MJ, Shafer RW, Winters MA, Katzenstein DA, Merigan TC. A mutation in human immunodeficiency virus reverse transcriptase and decline in CD4 lymphocyte numbers in long-term zidovudine recipients. J Infect Dis. 1993 Mar;167(3):526-32. doi: 10.1093/infdis/167.3.526.
PMID: 7680058BACKGROUNDMcCorkindale C, Dybevik K, Coulston AM, Sucher KP. Nutritional status of HIV-infected patients during the early disease stages. J Am Diet Assoc. 1990 Sep;90(9):1236-41.
PMID: 2168908BACKGROUNDLin DY, Fischl MA, Schoenfeld DA. Evaluating the role of CD4-lymphocyte counts as surrogate endpoints in human immunodeficiency virus clinical trials. Stat Med. 1993 May 15;12(9):835-42. doi: 10.1002/sim.4780120904.
PMID: 8101011BACKGROUNDLagakos S, Fischl MA, Stein DS, Lim L, Volberding P. Effects of zidovudine therapy in minority and other subpopulations with early HIV infection. JAMA. 1991 Nov 20;266(19):2709-12.
PMID: 1942422BACKGROUNDMelnick SL, Hannan P, Decher L, Little JW, Rhame FS, Balfour HH Jr, Volberding P. Increasing CD8+ T lymphocytes predict subsequent development of intraoral lesions among individuals in the early stages of infection by the human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1991;4(12):1199-207.
PMID: 1682473BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
MA Fischl
- STUDY CHAIR
DD Richman
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1995
Last Updated
November 4, 2021
Record last verified: 2021-10