Comparison of ddI Versus Zidovudine in HIV-Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000979

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1500

Last updated by the study team

2011-03-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

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.
• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Palo Alto Veterans Adm Med Ctr / Stanford Univ — Palo Alto, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Olive View Med Ctr — Sylmar, California, United States
• Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr — Sylmar, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Mountain States Regional Hemophilia Ctr / Univ of Colorado — Denver, Colorado, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Whitman - Walker Clinic — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• G E Morey Jr — Fort Lauderdale, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Edward Hines Veterans Administration Hosp — Hines, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Louisiana Comprehensive Hemophilia Care Ctr — New Orleans, Louisiana, United States
• Louisiana State Univ Med Ctr / Tulane Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.