NCT00002347

Brief Summary

To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ). Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

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

June 24, 2005

Status Verified

June 1, 1995

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

ZalcitabineDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudineNevirapineSaquinavir

Interventions

SaquinavirDRUG
NevirapineDRUG
ZidovudineDRUG
ZalcitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Medication:
  • Encouraged:
  • PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study.
  • Allowed:
  • Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
  • Acyclovir for 21 days or less for acute treatment.
  • Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively.
  • Patients must have:
  • HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • No prior antiretroviral therapy.
  • Life expectancy of at least 48 weeks.
  • Consent of parent or guardian if less than 18 years of age.
  • NOTE:
  • Participating centers are encouraged to enroll female patients.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Any grade 3 or greater toxicity.
  • Symptoms of peripheral neuropathy.
  • Malabsorption or severe chronic diarrhea.
  • Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort.
  • Concurrent Medication:
  • Excluded during the first 28 days of nevirapine administration:
  • Augmentin and other antibiotics containing clavulanic acid.
  • Excluded at any time:
  • Dicumarol, warfarin, and other anticoagulant medications.
  • Tolbutamide.
  • Cimetidine.
  • Erythromycin.
  • Patients with the following prior conditions are excluded:
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAREXEL Intl Corp / InterCo Collaboration Ctr

Waltham, Massachusetts, 02154, United States

Location

Related Publications (1)

  • Thompson M, Myers M, Salgo M, Rousseau F, Odorisio M, Warburg M. A master protocol to evaluate the safety and efficacy of multidrug combination antiretroviral therapy with zidovudine and zalcitabine with or without saquinavir or nevirapine for the treatment of HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:109 (abstract no 242)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

SaquinavirNevirapineZidovudineZalcitabine

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 CompoundsQuinolinesPyridinesHeterocyclic Compounds, 1-RingThymidinePyrimidine NucleosidesPyrimidinesDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDeoxycytidineCytidine

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1995-06

Locations

US(1)