A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine

Completed · Phase 2

Conditions studied: HIV Infections

In brief

To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers. Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.

Key facts

Study ID

NCT00000770

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

400

Expected to finish

1994-11-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Required:
• PCP prophylaxis for patients with CD4 count < 200 cells/mm3 or a prior history of PCP.
• Allowed:
• Trimethoprim with sulfamethoxazole or dapsone, intravenous pentamidine, atovaquone, primaquine-clindamycin or trimetrexate for acute PCP.
• Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for treatment of mucosal and esophageal candidiasis.
• Prophylaxis or therapy for opportunistic infections, as indicated, with other medications such as itraconazole, isoniazid, pyrazinamide, clofazimine, clarithromycin, azithromycin, ethambutol, amikacin, ciprofloxacin, ofloxacin, pyrimethamine, sulfadiazine, and clindamycin.
• Maintenance therapy for opportunistic infections as long as patients have been on a stable dosage regimen for 1 month prior to study entry.
• Ganciclovir for CMV retinitis or gastrointestinal disease as long as patients have been on a stable dose for at least 1 month prior to study entry with no grade 3 or 4 neutropenia or dependence on G-CSF.
• Acyclovir (<= 1000 mg/day) for maintenance of herpes simplex virus infections.
• Erythropoietin or G-CSF if clinically indicated.
• Antibiotics for bacterial infections unless specifically excluded.
• Rifampin or rifabutin.
• Symptomatic treatments such as antipyretics, analgesics, and antiemetics.
• Concurrent Treatment:
• Allowed:
• Local radiation therapy.
• Prior Medication: Required:
• At least 6 months of prior cumulative nucleoside therapy with AZT, ddI, or ddC, given as monotherapy or in combination.
• Patients must have:
• Prior or current documentation of HIV seropositivity by ELISA confirmed by Western blot, positive HIV antigen, or positive HIV culture, or a second antibody test by a method other than ELISA.
• CD4 count <= 350 cells/mm3.
• Prior cumulative nucleoside therapy of >= 6 months.
• Consent of parent or guardian if less than 18 years of age.

You may not qualify if…

• Concurrent Medication:
• Excluded:
• Antiretroviral therapies other than study medications.
• Systemic corticosteroids given consecutively for > 21 days.
• Induction or maintenance with foscarnet.
• Systemic cytotoxic chemotherapy for a malignancy.
• Erythromycin.
• Coumadin/warfarin.
• Phenytoin or phenobarbital.
• Amoxicillin/clavulanate acid (Augmentin) or ticarcillin/clavulanate acid (Timentin).
• Patients with the following prior conditions are excluded:
• History of pancreatitis.
• History of intolerance to 500 or 600 mg/day AZT or to 400 mg/day ddI tablets or 500 mg/day ddI sachets.
• History of grade 2 or worse peripheral neuropathy.
• Prior Medication:
• Excluded at any time:
• Prior non-nucleoside reverse transcriptase inhibitors (NVP; L697,611; TIBO; atevirdine).
• Excluded within 14 days prior to study entry:
• Acute treatment for a serious infection or any opportunistic infection.
• Biologic response modifiers such as interferon and IL-2.
• Erythromycin.
• Coumadin/warfarin.
• Phenytoin or phenobarbital.
• Ticarcillin/clavulanate acid (Timentin) or amoxicillin/clavulanate acid (Augmentin).

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
• Summitt Med Ctr / San Francisco Gen Hosp — Oakland, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, 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
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Iowa Hosp and Clinic — Iowa City, Iowa, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Hennepin County Med Clinic — Minneapolis, Minnesota, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• St Paul Ramsey Med Ctr — Saint Paul, Minnesota, United States
• Univ of Nebraska Med Ctr — Omaha, Nebraska, United States
• City Hosp Ctr at Elmhurst / Mount Sinai Hosp — Elmhurst, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Saint Clare's Hosp and Health Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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