NCT00001040

Brief Summary

PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

May 1, 1994

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

First QC Date

November 2, 1999

Last Update Submit

February 28, 2011

Conditions

HIV Infections

Keywords

ZalcitabineDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudineSaquinavirHIV Protease Inhibitors

Interventions

SaquinavirDRUG
ZidovudineDRUG
ZalcitabineDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prior Medication: Required:
  • At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy.
  • Patients must have:
  • HIV seropositivity.
  • Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
  • CD4 count \> 50 to \<= 300 cells/mm3.
  • Life expectancy of at least 6 months.
  • Prior AZT therapy.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
  • Known intolerance to Ro 31-8959, AZT, or ddC.
  • Symptoms suggestive of pancreatitis.
  • Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding.
  • Visceral Kaposi's sarcoma.
  • Lymphoma that will require therapy within the next 6 months.
  • Transfusion dependence.
  • Concurrent Medication:
  • Excluded:
  • Investigational or antineoplastic agents.
  • Concurrent Treatment:
  • Excluded:
  • Radiotherapy (other than local skin radiotherapy).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Ohio State Univ Hosp

Columbus, Ohio, 432101228, United States

Location

Girard Med Ctr

Philadelphia, Pennsylvania, 191046073, United States

Location

Univ TX Galveston Med Branch

Galveston, Texas, 775550882, United States

Location

Univ of Washington

Seattle, Washington, 98122, United States

Location

Related Publications (9)

  • Schapiro JM, Lawrence J, Speck R, Winters MA, Efron B, Coombs RW, Collier AC, Merigan TC. Resistance mutations to zidovudine and saquinavir in patients receiving zidovudine plus saquinavir or zidovudine and zalcitabine plus saquinavir in AIDS clinical trials group 229. J Infect Dis. 1999 Jan;179(1):249-53. doi: 10.1086/314541.

    PMID: 9841849BACKGROUND

  • Brambilla D, Coombs R, Bremer JW, Reichelderfer PS, Kalish L, Shapiro DE. The contributions of assay variation and biological variation to the variability of HIV RNA measurements in serially collected clinical specimens. Int Conf AIDS. 1998;12:805 (abstract no 42163)

    BACKGROUND

  • Collier AC, Coombs RW, Schoenfeld DA, Bassett R, Baruch A, Corey L. Combination therapy with zidovudine, didanosine and saquinavir. Antiviral Res. 1996 Jan;29(1):99. doi: 10.1016/0166-3542(95)00928-0.

    PMID: 8721557BACKGROUND

  • Collier AC, Coombs RW, Timpone J, Schoenfeld DA, Bassett R, Baruch A, Corey L. Comparative study of Ro 31-8959 and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. Ro 31-8959, ZDV, and ddC. The ACTG 229 Protocol Team. Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no 058B)

    BACKGROUND

  • Noble S, Faulds D. Saquinavir. A review of its pharmacology and clinical potential in the management of HIV infection. Drugs. 1996 Jul;52(1):93-112. doi: 10.2165/00003495-199652010-00007.

    PMID: 8799687BACKGROUND

  • Vanhove GF, Gries JM, Verotta D, Sheiner LB, Coombs R, Collier AC, Blaschke TF. Exposure-response relationships for saquinavir, zidovudine, and zalcitabine in combination therapy. Antimicrob Agents Chemother. 1997 Nov;41(11):2433-8. doi: 10.1128/AAC.41.11.2433.

    PMID: 9371346BACKGROUND

  • Collier AC, Coombs RW, Schoenfeld DA, Bassett RL, Timpone J, Baruch A, Jones M, Facey K, Whitacre C, McAuliffe VJ, Friedman HM, Merigan TC, Reichman RC, Hooper C, Corey L. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group. N Engl J Med. 1996 Apr 18;334(16):1011-7. doi: 10.1056/NEJM199604183341602.

    PMID: 8598838BACKGROUND

  • Fischl MA, Stanley K, Collier AC, Arduino JM, Stein DS, Feinberg JE, Allan JD, Goldsmith JC, Powderly WG. Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. The NIAID AIDS Clinical Trials Group. Ann Intern Med. 1995 Jan 1;122(1):24-32. doi: 10.7326/0003-4819-122-1-199501010-00004.

    PMID: 7985892BACKGROUND

  • Schapiro JM, Lawrence J, Speck R, Winters MA, Coombs R, Collier AC, Efron B, Merigan TC. HIV RNA and resistance mutations to saquinavir and zidovudine in patients receiving dual versus triple combination therapy. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:154 (abstract no 401)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

SaquinavirZidovudineZalcitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolinesThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDeoxycytidineCytidine

Study Officials

  • Collier AC

    STUDY CHAIR

  • Corey L

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

May 1, 1994

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

US(10)