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Comparison of ddI Versus Zidovudine in HIV-Infected Patients

11 maart 2011 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection

To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts < 200 cells/mm3.

AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.

Studie Overzicht

Toestand

Voltooid

Conditie

HIV-infecties

Interventie / Behandeling

Gedetailleerde beschrijving

AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels.

It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.

Studietype

Ingrijpend

Inschrijving

1500

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Puerto Rico
- - San Juan, Puerto Rico, 009275800
    - San Juan Veterans Administration Med Ctr
Verenigde Staten
- California
  - Los Angeles, California, Verenigde Staten, 900276016
    - Children's Hosp of Los Angeles/UCLA Med Ctr
  - Los Angeles, California, Verenigde Staten, 90033
    - Los Angeles County - USC Med Ctr
  - Palo Alto, California, Verenigde Staten, 94304
    - Palo Alto Veterans Adm Med Ctr / Stanford Univ
  - San Diego, California, Verenigde Staten, 921036325
    - Univ of California / San Diego Treatment Ctr
  - Stanford, California, Verenigde Staten, 94305
    - Stanford Univ School of Medicine
  - Sylmar, California, Verenigde Staten, 91342
    - Olive View Med Ctr
  - Sylmar, California, Verenigde Staten, 91342
    - Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
  - Torrance, California, Verenigde Staten, 90502
    - Harbor UCLA Med Ctr
- Colorado
  - Denver, Colorado, Verenigde Staten, 80262
    - Univ of Colorado Health Sciences Ctr
  - Denver, Colorado, Verenigde Staten, 80262
    - Mountain States Regional Hemophilia Ctr / Univ of Colorado
- District of Columbia
  - Washington, District of Columbia, Verenigde Staten, 20037
    - George Washington Univ Med Ctr
  - Washington, District of Columbia, Verenigde Staten, 20009
    - Whitman - Walker Clinic
- Florida
  - Fort Lauderdale, Florida, Verenigde Staten, 33316
    - G E Morey Jr
  - Miami, Florida, Verenigde Staten, 331361013
    - Univ of Miami School of Medicine
- Illinois
  - Chicago, Illinois, Verenigde Staten, 60611
    - Northwestern Univ Med School
  - Chicago, Illinois, Verenigde Staten, 60612
    - Rush Presbyterian - Saint Luke's Med Ctr
  - Chicago, Illinois, Verenigde Staten, 60612
    - Cook County Hosp
  - Hines, Illinois, Verenigde Staten, 60141
    - Edward Hines Veterans Administration Hosp
- Indiana
  - Indianapolis, Indiana, Verenigde Staten, 462025250
    - Indiana Univ Hosp
- Kansas
  - Wichita, Kansas, Verenigde Staten, 67214
    - Univ of Kansas School of Medicine
- Louisiana
  - New Orleans, Louisiana, Verenigde Staten, 70112
    - Louisiana Comprehensive Hemophilia Care Ctr
  - New Orleans, Louisiana, Verenigde Staten, 70112
    - Louisiana State Univ Med Ctr / Tulane Med School
  - New Orleans, Louisiana, Verenigde Staten, 70112
    - Tulane Univ School of Medicine
  - New Orleans, Louisiana, Verenigde Staten, 70112
    - Charity Hosp / Tulane Univ Med School
- Maryland
  - Baltimore, Maryland, Verenigde Staten, 21287
    - Johns Hopkins Hosp
- Massachusetts
  - Boston, Massachusetts, Verenigde Staten, 02114
    - Harvard (Massachusetts Gen Hosp)
  - Boston, Massachusetts, Verenigde Staten, 02118
    - Boston Med Ctr
  - Boston, Massachusetts, Verenigde Staten, 02215
    - Beth Israel Deaconess - West Campus
  - Boston, Massachusetts, Verenigde Staten, 02215
    - Beth Israel Deaconess Med Ctr
  - Springfield, Massachusetts, Verenigde Staten, 01199
    - Baystate Med Ctr of Springfield
  - Worcester, Massachusetts, Verenigde Staten, 01605
    - Med Ctr of Central Massachusetts
  - Worcester, Massachusetts, Verenigde Staten, 01655
    - Univ of Massachusetts Med Ctr
- Minnesota
  - Minneapolis, Minnesota, Verenigde Staten, 55455
    - Univ of Minnesota
- Nebraska
  - Omaha, Nebraska, Verenigde Staten, 68105
    - Nebraska Regional Hemophilia Ctr
- New York
  - Bronx, New York, Verenigde Staten, 10461
    - Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  - Bronx, New York, Verenigde Staten, 10465
    - Jack Weiler Hosp / Bronx Municipal Hosp
  - Bronx, New York, Verenigde Staten, 10467
    - Montefiore Med Ctr / Bronx Municipal Hosp
  - Bronx, New York, Verenigde Staten, 10468
    - Bronx Veterans Administration / Mount Sinai Hosp
  - Buffalo, New York, Verenigde Staten, 14215
    - SUNY / Erie County Med Ctr at Buffalo
  - Elmhurst, New York, Verenigde Staten, 11373
    - City Hosp Ctr at Elmhurst / Mount Sinai Hosp
  - New York, New York, Verenigde Staten, 10021
    - Cornell Univ Med Ctr
  - New York, New York, Verenigde Staten, 10003
    - Beth Israel Med Ctr / Peter Krueger Clinic
  - New York, New York, Verenigde Staten, 10016
    - Bellevue Hosp / New York Univ Med Ctr
  - New York, New York, Verenigde Staten, 10021
    - Mem Sloan - Kettering Cancer Ctr
  - New York, New York, Verenigde Staten, 10025
    - Saint Luke's - Roosevelt Hosp Ctr
  - New York, New York, Verenigde Staten, 10029
    - Mount Sinai Med Ctr
  - Rochester, New York, Verenigde Staten, 14642
    - Univ of Rochester Medical Center
  - Stony Brook, New York, Verenigde Staten, 117948153
    - SUNY - Stony Brook
  - Syracuse, New York, Verenigde Staten, 13210
    - SUNY / State Univ of New York
- North Carolina
  - Chapel Hill, North Carolina, Verenigde Staten, 275997215
    - Univ of North Carolina
  - Durham, North Carolina, Verenigde Staten, 27710
    - Duke Univ Med Ctr
  - Winston-Salem, North Carolina, Verenigde Staten, 27103
    - Bowman Gray School of Medicine / Wake Forest Univ
- Ohio
  - Cincinnati, Ohio, Verenigde Staten, 452670405
    - Holmes Hosp / Univ of Cincinnati Med Ctr
  - Columbus, Ohio, Verenigde Staten, 432101228
    - Ohio State Univ Hosp Clinic
  - Toledo, Ohio, Verenigde Staten, 43699
    - Med College of Ohio
- Pennsylvania
  - Hershey, Pennsylvania, Verenigde Staten, 170330850
    - Milton S Hershey Med Ctr
  - Philadelphia, Pennsylvania, Verenigde Staten, 19104
    - Univ of Pennsylvania
  - Pittsburgh, Pennsylvania, Verenigde Staten, 15219
    - Hemophilia Ctr of Western PA / Univ of Pittsburgh
  - Pittsburgh, Pennsylvania, Verenigde Staten
    - Univ of Pittsburgh Med School
- South Carolina
  - West Columbia, South Carolina, Verenigde Staten, 29169
    - Julio Arroyo
- Tennessee
  - Knoxville, Tennessee, Verenigde Staten, 37920
    - Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Texas
  - Galveston, Texas, Verenigde Staten, 77550
    - Univ TX Galveston Med Branch
  - Houston, Texas, Verenigde Staten, 77030
    - Hermann Hosp / Univ Texas Health Science Ctr
  - Houston, Texas, Verenigde Staten, 77030
    - Texas Children's Hosp / Baylor Univ
- Utah
  - Salt Lake City, Utah, Verenigde Staten, 84132
    - Univ of Utah School of Medicine
- Virginia
  - Hampton, Virginia, Verenigde Staten, 23666
    - Dr Stephen L Green
- Washington
  - Seattle, Washington, Verenigde Staten, 98105
    - Univ of Washington
- Wisconsin
  - Milwaukee, Wisconsin, Verenigde Staten, 53215
    - Dr Brian Buggy
  - Milwaukee, Wisconsin, Verenigde Staten, 53226
    - Milwaukee County Med Complex
  - Milwaukee, Wisconsin, Verenigde Staten, 53233
    - Great Lakes Hemophilia Foundation

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria

Concurrent Medication:

Required:

Aerosolized pentamidine (300 mg every 4 weeks using a Respirgard II nebulizer). In the event of physiological intolerance, alternative prophylaxis may be: Trimethoprim / sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg/day.

Allowed:

Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT).

Treatment of opportunistic infections with other than sulfonamide containing drugs:

Pyrimethamine and sulfadiazine or clindamycin for suppression of toxoplasmosis acquired after study entry; fluconazole or amphotericin B for suppression of cryptococcosis or ketoconazole for candidiasis.

Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities.

Isoniazid (INH) if no other acceptable therapy is available.

Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note:

Ketoconazole and dapsone should be taken 2 hours before or 2 hours after taking ddI (amendment 5/20/91).

Concurrent Treatment:

Allowed:

Blood transfusions for hemoglobin toxicity.

Patients must:

Have a diagnosis of AIDS or advanced AIDS related complex (ARC), or per 8/09/90 amendment, asymptomatic HIV infection with CD4 count = or < 200 cells/mm3.
Be either naive to zidovudine (AZT) or have taken AZT for = or < 48 weeks.
Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. For patients with 2 months or less experience with AZT, PCP infection will be the single and only AIDS-defining infection and must have been within 120 days of study entry. Per amendment, other AIDS-defining conditions are allowed in the 8 weeks prior to study entry (for patients in the AZT stratum).Only one episode of PCP is permitted unless patient has > 2 months AZT experience in which case > 1 prior episode of PCP infection is allowed.
Not have experienced a major intolerance to AZT at doses of at least 500 mg if the patient was on AZT therapy for = or < 48 weeks. A major intolerance is defined as recurrent grade 3 or greater toxicity which results in discontinuation of drug.

Allowed:

Basal cell carcinoma.
In situ carcinoma of the cervix.
Occasional premature atrial or ventricular contraction.
Patients developing new opportunistic infections after study entry will remain on this protocol.
Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3.

Prior Medication:

Allowed:

Previous treatment with zidovudine (AZT) up to 48 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or diseases are excluded:

Kaposi's sarcoma (KS) with evidence of visceral disease or where KS requires chemotherapy; subjects with localized KS having CD4 counts = or > 200 cells/mm3.
AIDS-dementia complex = or > stage 2.
Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.
Intractable diarrhea.
History of seizures within past 6 months or currently requiring anticonvulsants for control.
History of past or current heart disease.
Presence of a malignancy likely in the investigators opinion to require cytotoxic myelosuppressive chemotherapy during the expected course of this trial.

Concurrent Medication:

Excluded:

Oral acidifying agents.
Neurotoxic drugs. NOTE: If patients require therapy for PCP with IV pentamidine, study mediation is stopped.

Patients with the following are excluded:

Active AIDS defining events. Maintenance therapy for prior AIDS-defining opportunistic infections is permitted.
Intolerance to AZT at doses of 500 mg because of recurrent grade 3 toxicity or greater which resulted in discontinuation of drug.
Neoplasms not specifically allowed.
Previous enrollment in any study of ddI, ddC or d4T.
> 48 weeks of AZT therapy.
An opportunistic infection not adequately controlled with suppressive therapies allowed in the protocol.
Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance study therapy.
Life expectancy = or < 6 months.

Prior Medication:

Excluded:

Ganciclovir.
AZT for = or > 48 weeks.

Excluded within 14 days of study entry:

Erythropoietin (Eprex).

Excluded within 30 days of study entry:

Anti-HIV therapy other than AZT.
Biologic response modifiers.
Other investigational drugs.
Corticosteroids.
Neurotoxic drugs.

Excluded within 90 days of study entry:

Ribavirin.

Prior Treatment:

Excluded within 14 days of study entry:

Transfusion.

Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

Bristol-Myers Squibb

Onderzoekers

Studie stoel: R Dolin

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

7 december 2022

Primaire voltooiing (Werkelijk)

1 oktober 1992

Studie voltooiing

7 december 2022

Studieregistratiedata

Eerst ingediend

2 november 1999

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2001

Eerst geplaatst (Schatting)

31 augustus 2001

Updates van studierecords

Laatste update geplaatst (Schatting)

14 maart 2011

Laatste update ingediend die voldeed aan QC-criteria

11 maart 2011

Laatst geverifieerd

1 januari 2003

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

ACTG 116
070V1
ACTG 116-A
ACTG 116-B/117
AI454-008

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .