Phase I/II Study of Curdlan Sulfate

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.

Completed

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ViRx Inc

San Francisco, California, 94109, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curdlan sulfate

Drug

Sponsors and collaborators

Lead sponsor

AJI Pharma USA

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed