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

Mucos Pharma

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Wobenzym

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002311

122A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.