HIV InfectionsPhase 1NCT00000690
Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
A Phase 1 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 evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dextran sulfate
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 1989
- Phase
- Phase 1
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Co-existing Condition:
- Volunteers with any of the following are excluded:
- Disorders of coagulation or disorders of plasma lipids.
- Allergy to dextran sulfate, other sulfates, other dextrans.
- Concurrent Medication:
- Excluded:
Show all 23Show fewer
- Volunteers who anticipate need for medication during study.
- Volunteers with any of the following are excluded:
- Disorders of coagulation or disorders of plasma lipids.
- Allergy to dextran sulfate, other sulfates, other dextrans.
- Prior Medication:
- Excluded within 2 weeks of study entry:
- Any medication.
- Risk Behavior:
- Excluded:
- Ingestion of alcohol within 48 hours prior to study.
- History of recent drug or alcohol abuse.
- Disorders of coagulation or disorders of plasma lipids.
- Allergy to dextran sulfate, other sulfates, other dextrans.
- Volunteers selected are:
- In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory.
- Consenting volunteers.
- Available for 6 days of continuous hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation.
DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
Read the detailed description
DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected.
- Conditions
- HIV Infections
- Being tested
- Dextran sulfate
- Keywords
- Reference Values, Infusions, Intravenous, Intestinal Absorption, Dextran Sulfate, Administration, Oral, Blood Coagulation
- Medical subject headings
- HIV Infections, Thrombosis
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 completionOct 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- P Lietman, Study chairKJ Lorentsen, Study chairCW Hendrix, Study chairJM Collins, Study chairDM Kornhauser, Study chairBG Petty, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000690
- Sponsor's protocol ID
- ACTG 078
- Other IDs
- 11053
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 2 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 1810188Hiebert LM, Wice SM, Jaques LB, Williams KE, Conly JM. Orally administered dextran sulfate is absorbed in HIV-positive individuals. J Lab Clin Med. 1999 Feb;133(2):161-70. doi: 10.1016/s0022-2143(99)90009-4.
PubMed 9989768Lorentsen KJ, Hendrix CW, Collins JM, Kornhauser DM, Petty BG, Klecker RW, Flexner C, Eckel RH, Lietman PS. Dextran sulfate is poorly absorbed after oral administration. Ann Intern Med. 1989 Oct 1;111(7):561-6. doi: 10.7326/0003-4819-111-7-561.
PubMed 2476054
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00000690
- Acronym / sponsor ID
- ACTG 078
- Conditions
- HIV Infections
- Keywords
- Reference Values, Infusions, Intravenous, Intestinal Absorption, Dextran Sulfate, Administration, Oral, Blood Coagulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1989 (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 evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation.
DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
Detailed description
DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- Disorders of coagulation or disorders of plasma lipids.
- Allergy to dextran sulfate, other sulfates, other dextrans.
- Volunteers who anticipate need for medication during study.
- Disorders of coagulation or disorders of plasma lipids.
- Allergy to dextran sulfate, other sulfates, other dextrans.
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 2 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.
- Background: PubMed 9989768Hiebert LM, Wice SM, Jaques LB, Williams KE, Conly JM. Orally administered dextran sulfate is absorbed in HIV-positive individuals. J Lab Clin Med. 1999 Feb;133(2):161-70. doi: 10.1016/s0022-2143(99)90009-4.
- Background: PubMed 2476054Lorentsen KJ, Hendrix CW, Collins JM, Kornhauser DM, Petty BG, Klecker RW, Flexner C, Eckel RH, Lietman PS. Dextran sulfate is poorly absorbed after oral administration. Ann Intern Med. 1989 Oct 1;111(7):561-6. doi: 10.7326/0003-4819-111-7-561.
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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.
P Lietman study chair
KJ Lorentsen study chair
CW Hendrix study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 0 inclusion and 23 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 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00000690, which also lists 3 linked publications.
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 2 Nov 2021.