Phase I/II Study of Curdlan Sulfate

A

AJI Pharma

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Curdlan sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002100
127A
LCPL 92-1-28

Details and patient eligibility

About

To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses for 7 days.

Full description

In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested. In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

  • HIV seropositivity.
  • No current AIDS-defining opportunistic infection, lymphoma, Kaposi's sarcoma, or other malignancy.
  • CD4 count < 500 cells/mm3.
  • No critical illness that would shorten life expectancy to < 16 weeks.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Antiretroviral or other experimental therapies.
  • Anticoagulants.
  • Steroids.
  • Cytotoxic or immunosuppressive agents.

Concurrent Treatment:

Excluded:

Radiotherapy.

Patients with the following prior condition are excluded:

History of heparin sensitivity.

Prior Medication:

Excluded within 1 month prior to study entry:

  • Antiretroviral or other experimental therapies.
  • Anticoagulants.
  • Steroids.
  • Cytotoxic or immunosuppressive agents.

Prior Treatment:

Excluded:

Radiotherapy within 1 month prior to study entry. Active IV drug abuse.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems