HIV InfectionsNCT00000684
Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
A study testing Dextran sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dextran sulfate
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 1991
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Acetaminophen.
- Patients must have:
- -
- Clinically documented AIDS or AIDS-related complex (ARC) defined as CDC group IVA or history of any of the findings that define CDC group IV subgroup C-2:
Show all 10Show fewer
- oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia, or nocardiosis.
- Prior Medication:
- Allowed:
- Acetaminophen.
Who cannot join
- Concurrent Treatment:
- Excluded:
- Intramuscular injections.
- Patients will be excluded from the study for the following reasons:
- Acute illness requiring hospitalization or antiviral drug therapy for treatment.
- Volunteers who have taken any antiviral medications, anticoagulants, antiplatelet medications, or any nonsteroidal anti-inflammatory drugs, except acetaminophen, within 2 weeks of study entry, or those who anticipate the need for such medication during the study.
Show all 25Show fewer
- Positive stool guaiac at screening.
- Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi sarcoma (with or without proven gastrointestinal involvement), and any known CNS lesions that might be prone to bleed.
- Allergy to dextran sulfate or heparin.
- Acute or asymptomatic HIV infection.
- Prior Medication:
- Excluded:
- Antiviral medications.
- Anticoagulants.
- Antiplatelet medications.
- Any nonsteroidal anti-inflammatory drugs (except acetaminophen).
- Prior Treatment:
- Excluded:
- Hospitalization for acute illness.
- Patients may not have any of the following diseases or symptoms:
- Allergy to dextran sulfate or heparin.
- Acute or asymptomatic HIV infection.
- Acute illness requiring hospitalization.
- Chronic anemia requiring transfusion within the past month.
- Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi's sarcoma, and any known CNS lesions which might be prone to bleed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
About this study
To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study.
Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously
Read the detailed description
Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously will have antiviral effects in patients who are infected with HIV.
Following tests for evaluation, patients are hospitalized for 14 days. They are admitted to the hospital in the afternoon and, starting the next morning, receive a continuous infusion of dextran sulfate through an intravenous line for 14 days. The infusion is adjusted to maintain an activated partial thromboplastin time (APTT) of 50 to 65 seconds. Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety. Patients' clinical condition, blood clotting, and blood platelets are monitored very closely.
- Conditions
- HIV Infections
- Being tested
- Dextran sulfate
- Keywords
- Infusions, Intravenous, Dextran Sulfate, Acquired Immunodeficiency Syndrome
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextran sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionApr 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lietman PS, Study chairFlexner CW, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000684
- Sponsor's protocol ID
- ACTG 105
- Other IDs
- 11080
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Flexner C, Barditch-Crovo PA, Kornhauser DM, Farzadegan H, Nerhood LJ, Chaisson RE, Bell KM, Lorentsen KJ, Hendrix CW, Petty BG, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Dec;35(12):2544-50. doi: 10.1128/AAC.35.12.2544.
PubMed 1810188
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
- ClinicalTrials.gov ID
- NCT00000684
- Acronym / sponsor ID
- ACTG 105
- Conditions
- HIV Infections
- Keywords
- Infusions, Intravenous, Dextran Sulfate, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Apr 1991 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study.
Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously
Detailed description
Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously will have antiviral effects in patients who are infected with HIV.
Following tests for evaluation, patients are hospitalized for 14 days. They are admitted to the hospital in the afternoon and, starting the next morning, receive a continuous infusion of dextran sulfate through an intravenous line for 14 days. The infusion is adjusted to maintain an activated partial thromboplastin time (APTT) of 50 to 65 seconds. Blood is withdrawn 5 times on the first day that patients receive dextran sulfate and at least once a day thereafter for safety. Patients' clinical condition, blood clotting, and blood platelets are monitored very closely.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acetaminophen.
- -
- Clinically documented AIDS or AIDS-related complex (ARC) defined as CDC group IVA or history of any of the findings that define CDC group IV subgroup C-2:
- oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia, or nocardiosis.
- Acetaminophen.
Key exclusion criteria (25 listed)
- Intramuscular injections.
- Acute illness requiring hospitalization or antiviral drug therapy for treatment.
- Volunteers who have taken any antiviral medications, anticoagulants, antiplatelet medications, or any nonsteroidal anti-inflammatory drugs, except acetaminophen, within 2 weeks of study entry, or those who anticipate the need for such medication during the study.
- Positive stool guaiac at screening.
- Disorders of coagulation or any known contraindication to anticoagulation, including but not limited to gastrointestinal or other serious bleeding, major trauma or surgery within the past 2 months, stroke or suspicion of central nervous system (CNS) bleeding, Kaposi sarcoma (with or without proven gastrointestinal involvement), and any known CNS lesions that might be prone to bleed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextran sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 1810188Flexner C, Barditch-Crovo PA, Kornhauser DM, Farzadegan H, Nerhood LJ, Chaisson RE, Bell KM, Lorentsen KJ, Hendrix CW, Petty BG, et al. Pharmacokinetics, toxicity, and activity of intravenous dextran sulfate in human immunodeficiency virus infection. Antimicrob Agents Chemother. 1991 Dec;35(12):2544-50. doi: 10.1128/AAC.35.12.2544.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lietman PS study chair
Flexner CW study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextran sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.