Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
2 other identifiers
interventional
3,200
1 country
43
Brief Summary
To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with a lower dose to see if side effects can be reduced. Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease, it is reasonable to try it in less advanced cases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
43 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 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must:
- Be HIV seropositive and asymptomatic.
- Have normal neurologic exam as defined by the Micro Neuro-AIDS assessment.
- Concurrent Medication
- Required: Prophylaxis for Pneumocystis carinii pneumonia (PCP). Aerosolized pentamidine is preferred but if not possible, Trimethoprim / sulfamethoxazole 1 DS tablet per day or Dapsone 50 - 100 mg per day is allowed.
You may not qualify if:
- Active drug or alcohol abuse sufficient to prevent adequate compliance with study therapy in the investigator's opinion.
- Co-existing Condition:
- Patients with the following diseases or conditions are excluded:
- Hemophilia.
- Oral candida infection documented by morphology or by response to antifungal therapy within 2 years of study entry.
- Oral hairy leukoplakia at any time prior to study entry.
- Herpes zoster infection (including single dermatome infection) within 2 years of study entry.
- Active diarrhea as defined by 3 or more liquid stools per day.
- Temperature \> 37.8 degrees C.
- Grade 1 impairment on two or more items (mild AIDS dementia complex) in the ACTG Micro Neuro-AIDS Assessment.
- Prior history of malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ.
- Patients with the following are excluded from entry:
- AIDS or AIDS-related complex defining symptoms.
- Significant, chronic underlying medical illnesses which would impair continuous participation in this 3-year clinical trial.
- Hemophilia.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, 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
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
Children's Hosp of San Francisco
San Francisco, California, 94118, United States
San Francisco AIDS Clinic
San Francisco, California, 94143, 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
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, 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
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
Mem Sloan - Kettering Cancer 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
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
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 (9)
Volberding PA, Lagakos SW, Grimes JM, Stein DS, Balfour HH Jr, Reichman RC, Bartlett JA, Hirsch MS, Phair JP, Mitsuyasu RT, et al. The duration of zidovudine benefit in persons with asymptomatic HIV infection. Prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group. JAMA. 1994 Aug 10;272(6):437-42.
PMID: 7913730BACKGROUNDChoi S, Lagakos SW, Schooley RT, Volberding PA. CD4+ lymphocytes are an incomplete surrogate marker for clinical progression in persons with asymptomatic HIV infection taking zidovudine. Ann Intern Med. 1993 May 1;118(9):674-80. doi: 10.7326/0003-4819-118-9-199305010-00003.
PMID: 8096373BACKGROUNDVolberding PA, Lagakos SW, Grimes JM, Stein DS, Rooney J, Meng TC, Fischl MA, Collier AC, Phair JP, Hirsch MS, et al. A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter. AIDS Clinical Trials Group. N Engl J Med. 1995 Aug 17;333(7):401-7. doi: 10.1056/NEJM199508173330701.
PMID: 7616988BACKGROUNDVella S, Giuliano M, Dally LG, Agresti MG, Tomino C, Floridia M, Chiesi A, Fragola V, Moroni M, Piazza M, et al. Long-term follow-up of zidovudine therapy in asymptomatic HIV infection: results of a multicenter cohort study. The Italian Zidovudine Evaluation Group. J Acquir Immune Defic Syndr (1988). 1994 Jan;7(1):31-8.
PMID: 7903380BACKGROUNDVolberding PA, Lagakos SW, Koch MA, Pettinelli C, Myers MW, Booth DK, Balfour HH Jr, Reichman RC, Bartlett JA, Hirsch MS, et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. N Engl J Med. 1990 Apr 5;322(14):941-9. doi: 10.1056/NEJM199004053221401.
PMID: 1969115BACKGROUNDVolberding P. The value of the CD4+ count of 500 cells/microliters. Drugs. 1995;49 Suppl 1:4-8; discussion 38-40. doi: 10.2165/00003495-199500491-00004.
PMID: 7614901BACKGROUNDLenderking WR, Gelber RD, Cotton DJ, Cole BF, Goldhirsch A, Volberding PA, Testa MA. Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. The AIDS Clinical Trials Group. N Engl J Med. 1994 Mar 17;330(11):738-43. doi: 10.1056/NEJM199403173301102.
PMID: 7906386BACKGROUNDWu AW, Rubin HR, Mathews WC, Ware JE Jr, Brysk LT, Hardy WD, Bozzette SA, Spector SA, Richman DD. A health status questionnaire using 30 items from the Medical Outcomes Study. Preliminary validation in persons with early HIV infection. Med Care. 1991 Aug;29(8):786-98. doi: 10.1097/00005650-199108000-00011.
PMID: 1875745BACKGROUNDJacobson 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: 8528732BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Volberding P
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- 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 3, 2021
Record last verified: 2021-10