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NCT00000770

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

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1994-11-30

Brief Summary

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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.

Detailed Description

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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.

Patients are randomized to receive AZT/ddI plus either nevirapine or placebo daily for 48 weeks, with possible extension for at least 12 weeks. At eight participating sites, ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies.

Conditions

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HIV Infections

Keywords

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Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Nevirapine

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nevirapine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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).

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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D'Aquila R

Role: STUDY_CHAIR

Hirsch M

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

Highland Gen Hosp / San Francisco Gen Hosp

Oakland, California, United States

Site Status

Summitt Med Ctr / San Francisco Gen Hosp

Oakland, California, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States

Site Status

San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Northwestern Univ Med School

Chicago, Illinois, United States

Site Status

Cook County Hosp

Chicago, Illinois, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Indiana Univ Hosp

Indianapolis, Indiana, United States

Site Status

Univ of Iowa Hosp and Clinic

Iowa City, Iowa, United States

Site Status

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

Site Status

Boston Med Ctr

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Site Status

Hennepin County Med Clinic

Minneapolis, Minnesota, United States

Site Status

Univ of Minnesota

Minneapolis, Minnesota, United States

Site Status

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, United States

Site Status

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status

City Hosp Ctr at Elmhurst / Mount Sinai Hosp

Elmhurst, New York, United States

Site Status

Beth Israel Med Ctr

New York, New York, United States

Site Status

Saint Clare's Hosp and Health Ctr

New York, New York, United States

Site Status

Cornell Univ Med Ctr

New York, New York, United States

Site Status

Mem Sloan - Kettering Cancer Ctr

New York, New York, United States

Site Status