HIV InfectionsPhase 1NCT00004987
Treatment of Advanced AIDS Patients With Dextrin Sulfate
A Phase 1 study testing Dextrin 2-sulfate in people with HIV Infections, run by Steinhart Medical Associates at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dextrin 2-sulfate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
- Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
- Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
- Have used up all other treatment options.
- Are able to understand and give written consent.
Who cannot join
- Patients may not be eligible for this trial if they:
- Have been in any other study in the 6 weeks before beginning this study.
- Have an active, opportunistic infection or other infection.
- Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.
Read the detailed description
Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.
- Conditions
- HIV Infections
- Being tested
- Dextrin 2-sulfate
- Keywords
- Anti-HIV Agents, Viral Load, dextrin 2-sulfate, Infusions, Parenteral
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrin 2-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 startOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Steinhart Medical Associates
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004987
- Sponsor's protocol ID
- 309A
- Status last verified
- Jun 2001
- First submitted
- 16 Mar 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Dextrin Sulfate in Patients With Advanced HIV Disease: A Phase I Trial
- ClinicalTrials.gov ID
- NCT00004987
- Acronym / sponsor ID
- 309A
- Conditions
- HIV Infections
- Keywords
- Anti-HIV Agents, Viral Load, dextrin 2-sulfate, Infusions, Parenteral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Steinhart Medical AssociatesUniversity, hospital or other
- Study start
- Oct 1999
- 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.
The purpose of this study is to look at the safety and effectiveness of dextrin sulfate in AIDS patients who have failed conventional anti-HIV treatment.
Detailed description
Patients have intraperitoneal (IP) catheter placement done at study entry. Infusion with the carrier vehicle (icodextrin 4%) begins 2 weeks later, and 2 days after that, treatment with dextrin sulphate (DS) commences. DS is given three times per week. A nurse delivers initial treatments and the patient and caregiver will be trained to give subsequent treatments until DS has been given a total of 8 weeks. Patient evaluations are done regularly during treatment and observation continues for 24 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have been diagnosed with AIDS and are under treatment to prevent opportunistic (AIDS-related) infection.
- Have had a CD4 cell count greater than 50 microL for at least the past 3 months.
- Have had a viral load of at least 50,000 copies/ml for at least the past 3 months.
- Have used up all other treatment options.
Key exclusion criteria (4 listed)
- Have been in any other study in the 6 weeks before beginning this study.
- Have an active, opportunistic infection or other infection.
- Have any other long-term medical condition or nervous disorder that might make it difficult for them to finish the study.
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 |
|---|---|---|
| Dextrin 2-sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dextrin 2-sulfate in people with HIV Infections, run by Steinhart Medical Associates 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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?
Results are not available in the source record.
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?
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 24 Jun 2005.