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HIV InfectionsPhase 3NCT00000736

Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals

A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine
How many people
3,200 participants
Where
43 sitesUnited States
Study dates
Start not givento Feb 1995
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Holmes Hosp / Univ of Cincinnati Med Ctr

    Cincinnati, Ohio, 452670405

  • Univ Hosp of Cleveland / Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp

    Elmhurst, New York, 11373

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Beth Israel Med Ctr / Peter Krueger Clinic

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York, 10021

  • Saint Luke's - Roosevelt Hosp Ctr

    New York, New York, 10025

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Summitt Med Ctr / San Francisco Gen Hosp

    Oakland, California, 94609

  • Palo Alto Veterans Adm Med Ctr / Stanford Univ

    Palo Alto, California, 94304

  • Univ of Pittsburgh Med School

    Pittsburgh, Pennsylvania

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • San Francisco AIDS Clinic / San Francisco Gen Hosp

    San Francisco, California, 941102859

  • Stanford at Kaiser / Kaiser Permanente Med Ctr

    San Francisco, California, 94115

  • Children's Hosp of San Francisco

    San Francisco, California, 94118

  • San Francisco AIDS Clinic

    San Francisco, California, 94143

  • Univ of Washington

    Seattle, Washington, 98105

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St Louis, Missouri, 63112

  • Stanford Univ School of Medicine

    Stanford, California, 94305

  • SUNY - Stony Brook

    Stony Brook, New York, 117948153

  • SUNY / State Univ of New York

    Syracuse, New York, 13210

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Jack Weiler Hosp / Bronx Municipal Hosp

    The Bronx, New York, 10465

  • Montefiore Med Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10467

  • Bronx Veterans Administration / Mount Sinai Hosp

    The Bronx, New York, 10468

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • George Washington Univ Med Ctr

    Washington D.C., District of Columbia, 20037

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
HIV Infections
Being tested
Zidovudine
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Masking
Double blind
Enrolment
3,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000736
Sponsor's protocol ID
ACTG 019
Other IDs
10995
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 7913730

  • Choi 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.

    PubMed 8096373

  • Volberding 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.

    PubMed 7616988

  • Vella 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.

    PubMed 7903380

  • Volberding 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.

    PubMed 1969115

  • Volberding 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.

    PubMed 7614901

  • Lenderking 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.

    PubMed 7906386

  • Wu 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.

    PubMed 1875745

  • Jacobson 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.

    PubMed 8528732

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000736, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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