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AzTrials

HIV InfectionsPhase 2NCT00002333

A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine

A Phase 2 study testing Saquinavir and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 47 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Saquinavir and Zalcitabine
How many people
900 participants
Where
47 sitesin 3 countries
Study dates
Start not givento not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

47 sites in 3 countries.

47 sites in 3 countries

United States41 sites

  • Albany Med College

    Albany, New York, 12208

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • West Paces Clinical Research Incoporated

    Atlanta, Georgia, 30327

  • New England Med Ctr

    Boston, Massachusetts, 02111

  • Massachusetts Gen Hosp / Harvard Med School

    Boston, Massachusetts, 02114

  • New England Deaconess Hosp

    Boston, Massachusetts, 02215

  • UMDNJ - New Jersey Med School / Cooper Hosp

    Camden, New Jersey, 08103

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Ohio State Univ Hosp

    Columbus, Ohio, 43210

  • Oaklawn Physicians Group

    Dallas, Texas, 75219

  • Harper Hosp

    Detroit, Michigan, 48201

  • Univ TX Galveston Med Branch

    Galveston, Texas, 775550882

  • Kaiser Foundation Hosp

    Harbor City, California, 90710

  • Baylor College of Medicine

    Houston, Texas, 77005

  • UCSD

    La Jolla, California, 920930679

  • UCLA School of Medicine

    Los Angeles, California, 900121973

  • CARE Ctr / UCLA Med Ctr

    Los Angeles, California, 90095

  • Univ of Tennessee

    Memphis, Tennessee, 38163

  • Miami Veterans Administration Med Ctr

    Miami, Florida, 33125

  • Univ of Miami Dept of Medicine

    Miami, Florida, 33136

  • Stratogen of South Florida

    Miami Beach, Florida, 33140

  • Tulane Univ Med School

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Saint Vincent's Hosp and Med Ctr

    New York, New York, 10011

  • Harkness Pavilion

    New York, New York, 10032

  • UMDNJ - New Jersy Med School

    Newark, New Jersey, 08103

  • Thomas Jefferson Med College

    Philadelphia, Pennsylvania, 19107

  • Graduate Hosp / Tuttleman Cancer Ctr

    Philadelphia, Pennsylvania, 19146

  • Oregon Health Sciences Univ

    Portland, Oregon, 97201

  • UCD

    Sacramento, California, 95817

  • UCSF - San Francisco Gen Hosp

    San Francisco, California, 94110

  • Davies Med Ctr / c/o HIV Institute

    San Francisco, California, 94114

  • Mount Zion Med Ctr / UCSF

    San Francisco, California, 94115

  • San Francisco Veterans Administration Med Ctr

    San Francisco, California, 94121

  • Univ of Washington / Harborview Med Ctr

    Seattle, Washington, 98104

  • Pacific Oaks Med Group / Rsch & Scientific Investigation

    Sherman Oaks, California, 91403

  • Washington Univ School of Medicine

    St Louis, Missouri, 63108

  • Sunnyvale Med Clinic

    Sunnyvale, California, 94086

  • Harbor - UCLA Med Ctr

    Torrance, California, 90505

  • Veterans Administration Med Ctr

    Washington D.C., District of Columbia, 20422

  • Univ of Kansas School of Medicine

    Wichita, Kansas, 67214

Other trials in United States

Canada5 sites

  • Southern Alberta HIV Clinic

    Calgary, Alberta

  • McMaster Univ Med Ctr

    Hamilton, Ontario

  • Clinique Medicale L'Actuele

    Montreal, Quebec

  • Montreal Gen Hosp

    Montreal, Quebec

  • Sunnybrook Health Science Ctr

    Toronto, Ontario

Other trials in Canada

Puerto Rico1 site

  • San Juan Veterans Administration Med Ctr

    San Juan, 009275800

Other trials in Puerto Rico

About this study

Official title: 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

To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).

Read the detailed description

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.)

Conditions
HIV Infections
Being tested
Saquinavir, Zalcitabine
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Saquinavir, HIV Protease Inhibitors
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaquinavirDrug

  • ZalcitabineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
Double blind
Enrolment
900 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002333
Sponsor's protocol ID
229A
Other IDs
NV 14256B, NV 14256A
Status last verified
Feb 1995
First submitted
2 Nov 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • Revicki D, Swartz C. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir-zalcitabine therapy for advanced HIV-infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:113 (abstract no 266)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saquinavir and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 47 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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