The duration of zidovudine benefit in persons with asymptomatic HIV infection. Prolonged evaluation of protocol 019 of the AIDS Clinical Trials Group.
P A Volberding, S W Lagakos, J M Grimes...
https://pubmed.ncbi.nlm.nih.gov/7913730Completed
Phase 3
Age: 18Years +
All Genders
ID00000736
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03
3200
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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.
Exclusion Criteria
- 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.
Prior Medication: Excluded:
- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
- Other experimental medications.
- Excluded within 60 days of study entry:
- Antiretroviral drugs or immunomodulators (biologic response modifiers).
- Excluded within 120 days of study entry:
- Systemic corticosteroids.
Prior Treatment: Excluded within 3 months of study entry:
- Blood transfusion.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 43 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
3
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States, 94609
Status Unknown
4
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States, 94304
Status Unknown
5
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
6
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
7
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Status Unknown
8
Children's Hosp of San Francisco
San Francisco, California, United States, 94118
Status Unknown
9
San Francisco AIDS Clinic
San Francisco, California, United States, 94143
Status Unknown
10
Stanford Univ School of Medicine
Stanford, California, United States, 94305
Status Unknown
11
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
12
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States, 20037
Status Unknown
13
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
14
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
15
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
16
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
17
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
18
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
Status Unknown
19
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
20
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
21
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
22
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States, 11373
Status Unknown
23
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States, 10003
Status Unknown
24
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
25
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
26
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
27
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Status Unknown
28
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
29
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
30
SUNY - Stony Brook
Stony Brook, New York, United States, 117948153
Status Unknown
31
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Status Unknown
32
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
33
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10465
Status Unknown
34
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
35
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States, 10468
Status Unknown
36
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
37
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States, 452670405
Status Unknown
38
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
39
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
40
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
41
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Status Unknown
42
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
43
Univ of Washington
Seattle, Washington, United States, 98105
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
CD4+ lymphocytes are an incomplete surrogate marker for clinical progression in persons with asymptomatic HIV infection taking zidovudine.
S Choi, S W Lagakos, R T Schooley...
https://pubmed.ncbi.nlm.nih.gov/8096373A 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.
P A Volberding, S W Lagakos, J M Grimes...
https://pubmed.ncbi.nlm.nih.gov/7616988Long-term follow-up of zidovudine therapy in asymptomatic HIV infection: results of a multicenter cohort study. The Italian Zidovudine Evaluation Group.
S Vella, M Giuliano, L G Dally...
https://pubmed.ncbi.nlm.nih.gov/7903380Zidovudine 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.
P A Volberding, S W Lagakos, M A Koch...
https://pubmed.ncbi.nlm.nih.gov/1969115The value of the CD4+ count of 500 cells/microliters.
P Volberding
https://pubmed.ncbi.nlm.nih.gov/7614901Evaluation of the quality of life associated with zidovudine treatment in asymptomatic human immunodeficiency virus infection. The AIDS Clinical Trials Group.
W R Lenderking, R D Gelber, D J Cotton...
https://pubmed.ncbi.nlm.nih.gov/7906386A health status questionnaire using 30 items from the Medical Outcomes Study. Preliminary validation in persons with early HIV infection.
A W Wu, H R Rubin, W C Mathews...
https://pubmed.ncbi.nlm.nih.gov/1875745Zidovudine side effects as reported by black, Hispanic, and white/non-Hispanic patients with early HIV disease: combined analysis of two multicenter placebo-controlled trials.
M A Jacobson, H Gundacker, M Hughes...
https://pubmed.ncbi.nlm.nih.gov/8528732