NCT00001009

Brief Summary

To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in patients with AIDS and severe ARC, it has significant blood toxicities. It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity. DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of DS with AZT has been shown to be more effective than either alone.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 1990

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

T-LymphocytesHIV AntigensDextran SulfateDose-Response Relationship, DrugDrug EvaluationDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Dextran sulfateDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia (PCP).
  • Acetaminophen.
  • Ketoconazole.
  • Consistently positive serum HIV p24 antigen = or \> 70 picograms/ml, defined by the Abbott HIV antigen test, on two occasions, each within 1 month prior to entry, separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy. Positive antibody to HIV with a federally licensed ELISA test kit.

You may not qualify if:

  • Patients with any negative HIV p24 antigen test within 1 month of entry are excluded. Hemophiliacs are excluded.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Biologic response modifiers.
  • Zidovudine (AZT) or other antiretroviral agents.
  • Other investigational drugs.
  • Excluded within 12 weeks of study entry:
  • Ribavirin.
  • Excluded:
  • Ongoing therapy and/or prophylaxis for an AIDS-defining opportunistic infection.
  • Anticoagulant drugs.
  • Systemic corticosteroids.
  • Aspirin.
  • Dextran sulfate.
  • Sedatives.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Univ of Massachusetts Med Ctr

Worcester, Massachusetts, 01655, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10025, United States

Location

Related Publications (2)

  • Falloon J, et al. 566C80 for the treatment of Pneumocystis carinii pneumonia in AIDS. Int Conf AIDS. 1991 Jun 16-21;7(2):241 (abstract no WB2239)

    BACKGROUND

  • Abrams D, Pettinelli C, Power M, Kubacki VB, Grieco MH, Henry WK. A phase I/II dose ranging trial of oral dextran sulfate in HIV p24 antigen positive individuals (ACTG 060): results of a safety and efficacy trial. Int Conf AIDS. 1989 Jun 4-9;5:404 (abstract no WBP315)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Dextran Sulfate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

DextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Abrams D

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

April 1, 1990

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(8)