The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
Official Title ^ICMJE	A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Wobenzym
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002311
Responsible Party
Study ID Numbers ^ICMJE	122A
Study Sponsor ^ICMJE	Mucos Pharma GmbH and Co
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1993
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP