AzTrials
AzTrials

HIV InfectionsPhase 2NCT00000979

Comparison of ddI Versus Zidovudine in HIV-Infected Patients

A Phase 2 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 71 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
HIV Infections
What is being tested?
Zidovudine and Didanosine
How many people
1,500 participants
Where
71 sitesin 2 countries
Study dates
Start not givento Oct 1992
Phase
Phase 2
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 28Show fewer
  • 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.

Who cannot join

  • 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.
Show all 40Show fewer
  • 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.

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

United States70 sites

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • 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

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Holmes Hosp / Univ of Cincinnati Med Ctr

    Cincinnati, Ohio, 452670405

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Mountain States Regional Hemophilia Ctr / Univ of Colorado

    Denver, Colorado, 80262

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp

    Elmhurst, New York, 11373

  • G E Morey Jr

    Fort Lauderdale, Florida, 33316

  • Univ TX Galveston Med Branch

    Galveston, Texas, 77550

  • Dr Stephen L Green

    Hampton, Virginia, 23666

  • Milton S Hershey Med Ctr

    Hershey, Pennsylvania, 170330850

  • Edward Hines Veterans Administration Hosp

    Hines, Illinois, 60141

  • Hermann Hosp / Univ Texas Health Science Ctr

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

    Knoxville, Tennessee, 37920

  • Children's Hosp of Los Angeles/UCLA Med Ctr

    Los Angeles, California, 900276016

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Dr Brian Buggy

    Milwaukee, Wisconsin, 53215

  • Milwaukee County Med Complex

    Milwaukee, Wisconsin, 53226

  • Great Lakes Hemophilia Foundation

    Milwaukee, Wisconsin, 53233

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Charity Hosp / Tulane Univ Med School

    New Orleans, Louisiana, 70112

  • Louisiana Comprehensive Hemophilia Care Ctr

    New Orleans, Louisiana, 70112

  • Louisiana State Univ Med Ctr / Tulane Med School

    New Orleans, Louisiana, 70112

  • Tulane Univ School of Medicine

    New Orleans, Louisiana, 70112

  • 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

  • Nebraska Regional Hemophilia Ctr

    Omaha, Nebraska, 68105

  • Palo Alto Veterans Adm Med Ctr / Stanford Univ

    Palo Alto, California, 94304

  • Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Hemophilia Ctr of Western PA / Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Univ of Pittsburgh Med School

    Pittsburgh, Pennsylvania

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • Univ of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • Univ of Washington

    Seattle, Washington, 98105

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • Stanford Univ School of Medicine

    Stanford, California, 94305

  • SUNY - Stony Brook

    Stony Brook, New York, 117948153

  • Olive View Med Ctr

    Sylmar, California, 91342

  • Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr

    Sylmar, California, 91342

  • 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

  • Med College of Ohio

    Toledo, Ohio, 43699

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • Whitman - Walker Clinic

    Washington D.C., District of Columbia, 20009

  • George Washington Univ Med Ctr

    Washington D.C., District of Columbia, 20037

  • Julio Arroyo

    West Columbia, South Carolina, 29169

  • Univ of Kansas School of Medicine

    Wichita, Kansas, 67214

  • Bowman Gray School of Medicine / Wake Forest Univ

    Winston-Salem, North Carolina, 27103

  • Med Ctr of Central Massachusetts

    Worcester, Massachusetts, 01605

  • Univ of Massachusetts Med Ctr

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico1 site

  • San Juan Veterans Administration Med Ctr

    San Juan, 009275800

Other trials in Puerto Rico

About this study

Official title: 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.

Read the detailed description

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.

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.

Conditions
HIV Infections
Being tested
Zidovudine, Didanosine
Keywords
Didanosine, Zidovudine
Medical subject headings
HIV Infections

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. Primary completionOct 1992

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 2
Primary purpose
Treatment
Enrolment
1,500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000979
Sponsor's protocol ID
ACTG 116
Other IDs
070V1, ACTG 116-A, ACTG 116-B/117, AI454-008
Status last verified
Jan 2003
First submitted
2 Nov 1999
Last updated
14 Mar 2011
Results posted
No

Publications

  • Dolin R, Amato DA, Fischl MA, Pettinelli C, Beltangady M, Liou SH, Brown MJ, Cross AP, Hirsch MS, Hardy WD, et al. Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. AIDS Clinical Trials Group. Arch Intern Med. 1995 May 8;155(9):961-74.

    PubMed 7726705

  • Bozzette SA, Hays RD, Berry SH, Kanouse DE. A Perceived Health Index for use in persons with advanced HIV disease: derivation, reliability, and validity. Med Care. 1994 Jul;32(7):716-31. doi: 10.1097/00005650-199407000-00005.

    PubMed 8028406

  • Fiscus SA, Heggem-Snow A, Troiani L, Wallmark E, Folds JD, Sheff B, van der Horst CM. Transient high titers of HIV-1 in plasma and progression of disease. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 May 1;9(1):51-7.

    PubMed 7712235

  • Schooley RT. Correlation between viral load measurements and outcome in clinical trials of antiviral drugs. AIDS. 1995 Dec;9 Suppl 2:S15-S19.

    PubMed 8775802

  • Kozal MJ, Kroodsma K, Winters MA, Shafer RW, Efron B, Katzenstein DA, Merigan TC. Didanosine resistance in HIV-infected patients switched from zidovudine to didanosine monotherapy. Ann Intern Med. 1994 Aug 15;121(4):263-8. doi: 10.7326/0003-4819-121-4-199408150-00005.

    PubMed 7518658

  • Fichtenbaum CJ, Clifford DB, Powderly WG. Risk factors for dideoxynucleoside-induced toxic neuropathy in patients with the human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):169-74. doi: 10.1097/00042560-199510020-00009.

    PubMed 7552481

  • Spino C, Kahn JO, Dolin R, Phair JP. Predictors of survival in HIV-infected persons with 50 or fewer CD4 cells/mm3. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Aug 15;15(5):346-55. doi: 10.1097/00042560-199708150-00004.

    PubMed 9342254

  • Richardson D, Liou SH, Kahn JO. Uric acid and didanosine compliance in AIDS clinical trials: an analysis of AIDS Clinical Trials Group protocols 116A and 116B/117. J Acquir Immune Defic Syndr (1988). 1993 Nov;6(11):1212-23.

    PubMed 8229656

  • Welles SL, Jackson JB, Yen-Lieberman B, Demeter L, Japour AJ, Smeaton LM, Johnson VA, Kuritzkes DR, D'Aquila RT, Reichelderfer PA, Richman DD, Reichman R, Fischl M, Dolin R, Coombs RW, Kahn JO, McLaren C, Todd J, Kwok S, Crumpacker CS. Prognostic value of plasma human immunodeficiency virus type 1 (HIV-1) RNA levels in patients with advanced HIV-1 disease and with little or no prior zidovudine therapy. AIDS Clinical Trials Group Protocol 116A/116B/117 Team. J Infect Dis. 1996 Oct;174(4):696-703. doi: 10.1093/infdis/174.4.696.

    PubMed 8843205

  • Coombs RW, Welles SL, Hooper C, Reichelderfer PS, D'Aquila RT, Japour AJ, Johnson VA, Kuritzkes DR, Richman DD, Kwok S, Todd J, Jackson JB, DeGruttola V, Crumpacker CS, Kahn J. Association of plasma human immunodeficiency virus type 1 RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV-1 RNA Working Groups. J Infect Dis. 1996 Oct;174(4):704-12. doi: 10.1093/infdis/174.4.704.

    PubMed 8843206

  • Mildvan D, Spritzler J, Grossberg SE, Fahey JL, Johnston DM, Schock BR, Kagan J. Serum neopterin, an immune activation marker, independently predicts disease progression in advanced HIV-1 infection. Clin Infect Dis. 2005 Mar 15;40(6):853-8. doi: 10.1086/427877. Epub 2005 Feb 18.

    PubMed 15736019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 71 sites in 2 countries.

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 28 inclusion and 40 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 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT00000979, which also lists 11 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 14 Mar 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in