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

A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002311
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Wobenzym, Hydrolases

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.

Interventions

DRUGWobenzym

Sponsors

Mucos Pharma GmbH and Co
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026