Search / Trial NCT00000979

Comparison of ddI Versus Zidovudine in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

Didanosine Zidovudine

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 toxicit...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00000979_2024-06-13.pdf

4.5 MB

NCT00000979_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Philadelphia, Pennsylvania, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

Springfield, Massachusetts, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

Worcester, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Houston, Texas, United States

Sylmar, California, United States

Torrance, California, United States

Miami, Florida, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Bronx, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

New York, New York, United States

San Juan, , Puerto Rico

Palo Alto, California, United States

Washington, District Of Columbia, United States

Pittsburgh, Pennsylvania, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Stanford, California, United States

Sylmar, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Fort Lauderdale, Florida, United States

Hines, Illinois, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Omaha, Nebraska, United States

Bronx, New York, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Hampton, Virginia, United States

Milwaukee, Wisconsin, United States

Milwaukee, Wisconsin, United States

Milwaukee, Wisconsin, United States

Galveston, Texas, United States

Salt Lake City, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0