A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001009 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: March 29, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Dextran sulfate | Phase 1 |
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.
The study will begin with 10 patients with AIDS, 10 with ARC, and 10 with asymptomatic HIV infection taking DS by mouth 3 times a day for 24 weeks. If the initial dose of DS is tolerated without significant side effects, the next group of patients will receive a higher dose. A third group of patients will be given either a higher or lower dose depending on the results of the earlier groups. Patients will be evaluated every other week for 12 weeks, then monthly for the remaining 16 weeks. Patients will have the option of continuing DS until the entire study is completed if the drug is well tolerated. Inhaled pentamidine for the prevention of Pneumocystis carinii pneumonia is allowed, but other investigational drugs are not. Drug effects on the HIV virus, immune function, and clinical condition will be monitored during the periodic evaluations.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Dose Ranging Trial of Oral Dextran Sulfate (UA001) in HIV Infected Individuals and in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS Related Complex (ARC) |
Actual Study Completion Date : | April 1990 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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.
Exclusion Criteria
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.
- Barbiturates.
Prior Treatment:
Excluded within 2 weeks of study entry:
- Transfusion.
Severe diarrhea:
- = or > 5 loose or watery stools per day. Significant malabsorption:
- > 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml. Transfusion dependent:
- Requiring 2 units of blood > once a month. Active opportunistic infection. Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within 1 month of entry, or concurrent neoplasms other than KS. Basal cell carcinoma of the skin or in situ carcinoma of the cervix. Hemorrhagic diseases such as hemophilia A or B or von Willebrand disease.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent adequate compliance with study therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001009
United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Massachusetts | |
Univ of Massachusetts Med Ctr | |
Worcester, Massachusetts, United States, 01655 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 |
Study Chair: | Abrams D |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001009 History of Changes |
Other Study ID Numbers: |
ACTG 060 11034 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
T-Lymphocytes HIV Antigens Dextran Sulfate Dose-Response Relationship, Drug |
Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome AIDS-Related Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Dextrans Anticoagulants Plasma Substitutes Blood Substitutes |