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Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals


Phase 3
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals


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.

Patients entered in the study are randomly assigned to one of two doses of AZT or to placebo
(inactive medication). Patients take 3 capsules 5 times a day (every 4 hours from 8 am until
12 pm).

The capsules contain either AZT or placebo and are identical in appearance so that neither
patient nor physician knows which treatment the patient is receiving. The higher dose
corresponds to the dose found to be useful in patients with AIDS or severe ARC. Patients
visit the clinic every 2 weeks for the first 16 weeks, then once a month after that for
evaluation. Treatment will continue until the results from the study have been analyzed,
which could be as long as 3 years. If side effects occur, the dose of study medication will
be decreased or temporarily stopped. If the side effects are severe, then study medication
will be stopped permanently.

AMENDED: Effective with Version 4 (900226), dosing for ALL patients on Phase 2 study drug,
regardless of CD4+ substudy, will proceed as open-label AZT. Original treatment assignments
employed in the > 500 cells/mm3 substudy during the period from August 16, 1989 through the
release of this new version. Also, toxicity management and dose modification of AZT for
patients receiving Phase 2 study drug have been changed.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Volberding P

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 019

NCT ID:

NCT00000736

Start Date:

Completion Date:

February 1995

Related Keywords:

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
Palo Alto Veterans Adm Med Ctr / Stanford UnivPalo Alto, California  94304
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, California  94115
Stanford Univ School of MedicineStanford, California  94305
Harbor UCLA Med CtrTorrance, California  90502
George Washington Univ Med CtrWashington, District of Columbia  20037
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess Med CtrBoston, Massachusetts  02215
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
Beth Israel Med Ctr / Peter Krueger ClinicNew York, New York  10003
SUNY - Stony BrookStony Brook, New York  117948153
SUNY / State Univ of New YorkSyracuse, New York  13210
Duke Univ Med CtrDurham, North Carolina  27710
Holmes Hosp / Univ of Cincinnati Med CtrCincinnati, Ohio  452670405
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, Ohio  44106
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Univ of Pittsburgh Med SchoolPittsburgh, Pennsylvania  
Univ of WashingtonSeattle, Washington  98105
Johns Hopkins HospBaltimore, Maryland  21287
Summitt Med Ctr / San Francisco Gen HospOakland, California  94609
Children's Hosp of San FranciscoSan Francisco, California  94118
San Francisco AIDS ClinicSan Francisco, California  94143
St Louis Regional Hosp / St Louis Regional Med CtrSt Louis, Missouri  63112
Columbus Children's HospColumbus, Ohio  432052696