NCT00000826

Brief Summary

To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in HIV-infected patients. Although prophylaxis for more than one opportunistic infection is emerging as a common clinical practice in patients with advanced HIV disease, little is known about possible adverse drug interactions. The need exists to define pharmacokinetics and pharmacodynamic adverse interactions of the many combination prophylactic regimens that may be prescribed.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 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

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
6 months 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

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

Bacterial InfectionsMycosesHIV Infections

Keywords

RifabutinTrimethoprim-Sulfamethoxazole CombinationAIDS-Related Opportunistic InfectionsDapsoneDrug InteractionsFluconazoleAcquired Immunodeficiency SyndromeAIDS-Related ComplexClarithromycinSulfamethoxazole-Trimethoprim

Interventions

ClarithromycinDRUG
RifabutinDRUG
Sulfamethoxazole-TrimethoprimDRUG
DapsoneDRUG
FluconazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy provided patient has been on a stable dose for at least 4 weeks prior to study entry.
  • Methadone for drug abuse programs provided patient has been on a stable dose for at least 4 weeks prior to the study.
  • Patients must have:
  • HIV infection.
  • CD4 count \>= 200 cells/mm3.
  • No active opportunistic infection.
  • Prior Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Methadone for drug abuse therapy.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Suspicion of gastrointestinal malabsorption problems (at discretion of investigator).
  • Known hypersensitivity to dapsone, SMX, or other sulfonamides, trimethoprim, clarithromycin, rifabutin or other rifamycins, fluconazole, or other azoles.
  • G-6-PD deficiency or methemoglobinemia (in Part C and D patients only).
  • Concurrent Medication:
  • Excluded:
  • Cytolytic agents.
  • Amiodarone.
  • Anesthetics, general.
  • Astemizole.
  • Azithromycin.
  • Barbiturates.
  • Carbamazepine.
  • Cimetidine.
  • +104 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ucsf Aids Crs

San Francisco, California, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

Related Publications (2)

  • Cheng B. Preventing opportunistic infections. PI Perspect. 1995 May;(no 16):14-5.

    PMID: 11362422BACKGROUND

  • Winter HR, Trapnell CB, Slattery JT, Jacobson M, Greenspan DL, Hooton TM, Unadkat JD. The effect of clarithromycin, fluconazole, and rifabutin on sulfamethoxazole hydroxylamine formation in individuals with human immunodeficiency virus infection (AACTG 283). Clin Pharmacol Ther. 2004 Oct;76(4):313-22. doi: 10.1016/j.clpt.2004.06.002.

    PMID: 15470330RESULT

MeSH Terms

Conditions

Bacterial InfectionsMycosesHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

ClarithromycinRifabutinTrimethoprim, Sulfamethoxazole Drug CombinationDapsoneFluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingDrug CombinationsPharmaceutical PreparationsTriazolesAzoles

Study Officials

  • Unadkat J

    STUDY CHAIR

  • Trapnell CB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

May 1, 1999

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(2)