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


Phase 2
13 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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.

Inclusion Criteria


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

D'Aquila R

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 241

NCT ID:

NCT00000770

Start Date:

Completion Date:

November 1994

Related Keywords:

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

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of California / San Diego Treatment CtrSan Diego, California  921036325
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Univ of Miami School of MedicineMiami, Florida  331361013
Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess Med CtrBoston, Massachusetts  02215
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Boston Med CtrBoston, Massachusetts  02118
Univ of MinnesotaMinneapolis, Minnesota  55455
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, New York  10461
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
Univ of North CarolinaChapel Hill, North Carolina  275997215
Summitt Med Ctr / San Francisco Gen HospOakland, California  94609
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Highland Gen Hosp / San Francisco Gen HospOakland, California  946021018
Cook County HospChicago, Illinois  60612
Univ of Iowa Hosp and ClinicIowa City, Iowa  52242
Hennepin County Med ClinicMinneapolis, Minnesota  55415
St Paul Ramsey Med CtrSt Paul, Minnesota  55101
Univ of Nebraska Med CtrOmaha, Nebraska  681985130
Montefiore Drug Treatment Ctr / Bronx Municipal HospBronx, New York  10461
Montefiore Family Health Ctr / Bronx Municipal HospBronx, New York  10461
Samaritan Village Inc / Bronx Municipal HospBronx, New York  10461
Comprehensive Health Care Ctr / Bronx Municipal HospBronx, New York  10461
North Central Bronx Hosp / Bronx Municipal HospBronx, New York  10467
Beth Israel Med CtrNew York, New York  10003
Saint Clare's Hosp and Health CtrNew York, New York  10019
Carolinas Med CtrCharlotte, North Carolina  28203
Moses H Cone Memorial HospGreensboro, North Carolina  27401
Wake County Dept of HealthRaleigh, North Carolina  27610
Univ of CincinnatiCincinnati, Ohio  452670405
Girard Med CtrPhiladelphia, Pennsylvania  191046073
Thomas Jefferson Univ HospPhiladelphia, Pennsylvania  191075098
Univ of Pennsylvania at PhiladelphiaPhiladelphia, Pennsylvania  19104