Comparison of ddI Versus Zidovudine in HIV-Infected Patients
Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection
5 other identifiers
interventional
1,500
2 countries
71
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
October 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 14, 2011
January 1, 2003
November 2, 1999
March 11, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +13 more criteria
You may not qualify if:
- 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.
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Olive View Med Ctr
Sylmar, California, 91342, United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
G E Morey Jr
Fort Lauderdale, Florida, 33316, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Louisiana Comprehensive Hemophilia Care Ctr
New Orleans, Louisiana, 70112, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Med Ctr of Central Massachusetts
Worcester, Massachusetts, 01605, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
Nebraska Regional Hemophilia Ctr
Omaha, Nebraska, 68105, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY - Stony Brook
Stony Brook, New York, 117948153, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston-Salem, North Carolina, 27103, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Dr Stephen L Green
Hampton, Virginia, 23666, United States
Univ of Washington
Seattle, Washington, 98105, United States
Dr Brian Buggy
Milwaukee, Wisconsin, 53215, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, United States
Great Lakes Hemophilia Foundation
Milwaukee, Wisconsin, 53233, United States
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Related Publications (11)
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.
PMID: 7726705BACKGROUNDBozzette 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.
PMID: 8028406BACKGROUNDFiscus 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.
PMID: 7712235BACKGROUNDSchooley RT. Correlation between viral load measurements and outcome in clinical trials of antiviral drugs. AIDS. 1995 Dec;9 Suppl 2:S15-S19.
PMID: 8775802BACKGROUNDKozal 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.
PMID: 7518658BACKGROUNDFichtenbaum 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.
PMID: 7552481BACKGROUNDSpino 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.
PMID: 9342254BACKGROUNDRichardson 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.
PMID: 8229656RESULTWelles 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.
PMID: 8843205RESULTCoombs 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.
PMID: 8843206RESULTMildvan 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.
PMID: 15736019RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R Dolin
- STUDY CHAIR
M Fischl