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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 Ctr Chicago, Illinois  60612
Univ of Kansas School of Medicine Wichita, Kansas  67214
Univ TX Galveston Med Branch Galveston, Texas  77550
Beth Israel Med Ctr New York, New York  10003
AIDS Research Consortium of Atlanta Atlanta, Georgia  30308
Massachusetts Gen Hosp / Harvard Med School Boston, Massachusetts  02114
New England Deaconess Hosp Boston, Massachusetts  02215
Baylor College of Medicine Houston, Texas  77030
UMDNJ - New Jersy Med School Newark, New Jersey  071032714
Veterans Administration Med Ctr Washington, District of Columbia  20422
San Francisco Veterans Administration Med Ctr San Francisco, California  94121
Miami Veterans Administration Med Ctr Miami, Florida  33125
Univ of Miami Dept of Medicine Miami, Florida  33136
UCSD San Diego, California  92103
Davies Med Ctr / c/o HIV Institute San Francisco, California  94114
Harbor - UCLA Med Ctr Torrance, California  90502
UCLA School of Medicine Los Angeles, California  900121973
Univ of Tennessee Memphis, Tennessee  38163
Thomas Jefferson Med College Philadelphia, Pennsylvania  19107
Saint Vincent's Hosp and Med Ctr New York, New York  10011
New England Med Ctr Boston, Massachusetts  02111
Harper Hosp Detroit, Michigan  48201
Washington Univ School of Medicine St. Louis, Missouri  63108
Ohio State Univ Hosp Columbus, Ohio  43210
CARE Ctr / UCLA Med Ctr Los Angeles, California  900951793
UCSF - San Francisco Gen Hosp San Francisco, California  94110
Graduate Hosp / Tuttleman Cancer Ctr Philadelphia, Pennsylvania  19146
Kaiser Foundation Hosp Harbor City, California  90710
UCD Sacramento, California  95817
Mount Zion Med Ctr / UCSF San Francisco, California  94115
Pacific Oaks Med Group / Rsch & Scientific Investigation Sherman Oaks, California  91403
Sunnyvale Med Clinic Sunnyvale, California  94086
Stratogen of South Florida Miami Beach, Florida  33140
West Paces Clinical Research Incoporated Atlanta, Georgia  30327
Tulane Univ Med School New Orleans, Louisiana  70112
UMDNJ - New Jersey Med School / Cooper Hosp Camden, New Jersey  08103
Albany Med College Albany, New York  12208
Harkness Pavilion New York, New York  10032
Oregon Health Sciences Univ Portland, Oregon  97201
Oaklawn Physicians Group Dallas, Texas  75219
Univ of Washington / Harborview Med Ctr Seattle, Washington  98104