Back to resultsThe Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wobenzym
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Wobenzym, Hydrolases
Eligibility Criteria
Inclusion Criteria Patients must have: HIV seropositivity with CD4 counts between 250 and 400 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to hydrolytic enzymes such as Wobenzym. Known sensitivity to lactose. Presumption that the patient will not comply with the dosing schedule or follow-up appointments. Concurrent Medication: Excluded: Concurrent use of immunosuppressive therapy or steroids.
Sites / Locations
- Saint Luke's - Roosevelt Hosp Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002311
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Mucos Pharma GmbH and Co
1. Study Identification
Unique Protocol Identification Number
NCT00002311
Brief Title
The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
Official Title
A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mucos Pharma GmbH and Co
4. Oversight
5. Study Description
Brief Summary
To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To evaluate the effect of Wobenzym on certain surrogate markers associated with progression of HIV disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Wobenzym, Hydrolases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Wobenzym
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV seropositivity with CD4 counts between 250 and 400 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Known hypersensitivity to hydrolytic enzymes such as Wobenzym.
Known sensitivity to lactose.
Presumption that the patient will not comply with the dosing schedule or follow-up appointments.
Concurrent Medication:
Excluded:
Concurrent use of immunosuppressive therapy or steroids.
Facility Information:
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
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