NCT00057486

Brief Summary

There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12) as part of a combination therapy for this parasite.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_1 hiv-infections

Status
terminated

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

Study Start

First participant enrolled

September 1, 1997

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

December 14, 2016

Status Verified

March 1, 2003

Enrollment Period

7.8 years

First QC Date

April 2, 2003

Last Update Submit

December 13, 2016

Conditions

HIV InfectionsCryptosporidiosis

Keywords

Chronic DiarrheaInterleukin 12

Interventions

IL-12DRUG

Eligibility Criteria

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

You may qualify if:

  • HIV infection
  • CD4 cell count \< 150 cells/µl
  • Stable antiretroviral regime that includes at least two nucleotide analogues for at least 4 weeks
  • Viral load \< 10,000 copies/ml
  • Chronic diarrhea, defined as three loose or watery bowel movements a day for 5 days per week over 3 weeks
  • Stool positive for Cryptosporidium and no other enteric pathogen (bacterial culture, C. difficile toxin assay, AFB stain, ova and parasite examination, and stain for microsporidia)
  • Karnofsky score \>= 70
  • Acceptable methods of contraception

You may not qualify if:

  • Pregnant
  • Active opportunistic infection
  • History of hypersensitivity or significant intolerance to aminoglycosides, macrolide antibiotics, or colony stimulating factors
  • Requires intravenous fluids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsCryptosporidiosis

Interventions

Interleukin-12

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesIntestinal Diseases, ParasiticParasitic DiseasesProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Arthur White

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 2, 2003

First Posted

April 3, 2003

Study Start

September 1, 1997

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 14, 2016

Record last verified: 2003-03