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A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy


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

Thank you

Trial Information

A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy


Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and
ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by
baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC,
was discontinued.)

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- G-CSF and erythropoietin.

- Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized
pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol,
fluconazole, itraconazole, acyclovir, clotrimazole, nystatin,
trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin,
and fansidar.

Concurrent Treatment:

Allowed:

- Limited localized radiation therapy to the skin.

Patients must have:

- Documented HIV infection.

- CD4 count 50 - 300 cells/mm3.

- Received prior AZT that has been discontinued at least 28 days prior to study entry.

- No active opportunistic infection requiring immediate treatment.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Signs or symptoms of peripheral neuropathy.

- Malabsorption or inadequate oral intake (defined as unable to eat one or more meals
daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.

- Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy
and/or radiotherapy within the next 48 weeks.

- Any grade 3 or worse laboratory or clinical abnormality.

- Inability to comply with protocol requirements.

Concurrent Medication:

Excluded:

- Other antiretroviral drugs.

- Experimental drugs.

- Nephrotoxic or hepatotoxic drugs.

- Drugs likely to cause peripheral neuropathy.

- Antineoplastic agents.

- Biologic response modifiers.

Concurrent Treatment:

Excluded:

- Radiation therapy other than limited localized therapy to skin.

Patients with the following prior conditions are excluded:

- History of non-Hodgkin's lymphoma.

- Unexplained fever >= 38.5 C (101.5 F) persisting for 14 days or longer within the 28
days prior to study entry.

- Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting
for 14 days or longer within the 28 days prior to study entry.

- History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

- Prior HIV proteinase inhibitor.

- Prior antiretroviral therapy other than AZT.

- Acute therapy for opportunistic infection within 14 days prior to study entry.

Prior Treatment:

Excluded:

- More than 3 units of blood in any 21-day period within 3 months prior to study entry.

Required:

- Prior AZT.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

229A

NCT ID:

NCT00002333

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Saquinavir
  • HIV Protease Inhibitors
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Rush Presbyterian - Saint Luke's Med CtrChicago, Illinois  60612
Univ of Kansas School of MedicineWichita, Kansas  67214
Univ TX Galveston Med BranchGalveston, Texas  77550
Beth Israel Med CtrNew York, New York  10003
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
Massachusetts Gen Hosp / Harvard Med SchoolBoston, Massachusetts  02114
New England Deaconess HospBoston, Massachusetts  02215
Baylor College of MedicineHouston, Texas  77030
UMDNJ - New Jersy Med SchoolNewark, New Jersey  071032714
Veterans Administration Med CtrWashington, District of Columbia  20422
San Francisco Veterans Administration Med CtrSan Francisco, California  94121
Miami Veterans Administration Med CtrMiami, Florida  33125
Univ of Miami Dept of MedicineMiami, Florida  33136
UCSDSan Diego, California  92103
Davies Med Ctr / c/o HIV InstituteSan Francisco, California  94114
Harbor - UCLA Med CtrTorrance, California  90502
UCLA School of MedicineLos Angeles, California  900121973
Univ of TennesseeMemphis, Tennessee  38163
Thomas Jefferson Med CollegePhiladelphia, Pennsylvania  19107
Saint Vincent's Hosp and Med CtrNew York, New York  10011
New England Med CtrBoston, Massachusetts  02111
Harper HospDetroit, Michigan  48201
Washington Univ School of MedicineSt. Louis, Missouri  63108
Ohio State Univ HospColumbus, Ohio  43210
CARE Ctr / UCLA Med CtrLos Angeles, California  900951793
UCSF - San Francisco Gen HospSan Francisco, California  94110
Graduate Hosp / Tuttleman Cancer CtrPhiladelphia, Pennsylvania  19146
Kaiser Foundation HospHarbor City, California  90710
UCDSacramento, California  95817
Mount Zion Med Ctr / UCSFSan Francisco, California  94115
Pacific Oaks Med Group / Rsch & Scientific InvestigationSherman Oaks, California  91403
Sunnyvale Med ClinicSunnyvale, California  94086
Stratogen of South FloridaMiami Beach, Florida  33140
West Paces Clinical Research IncoporatedAtlanta, Georgia  30327
Tulane Univ Med SchoolNew Orleans, Louisiana  70112
UMDNJ - New Jersey Med School / Cooper HospCamden, New Jersey  08103
Albany Med CollegeAlbany, New York  12208
Harkness PavilionNew York, New York  10032
Oregon Health Sciences UnivPortland, Oregon  97201
Oaklawn Physicians GroupDallas, Texas  75219
Univ of Washington / Harborview Med CtrSeattle, Washington  98104