A Phase 1 interventional study of Dextran sulfate in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 8 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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Among 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) — 10 open to participants now, 15 under way, 1 of them phase 3. HIV Infections · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 417th largest by enrollment of the 883 interventional ones that give a count, is one of 365 in phase 1, and was the 1st registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →10 of the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 12 countries. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Peru
Ages 18–60 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–55 · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States, Brazil, Peru
Ages 18–70
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,034 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 411 · Phase 2 276 · Phase 3 101 · Phase 4 10
First in 1984; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 59 across the 883 interventional studies, 174 across the 136 observational. Of the 962 that completed or were terminated, 130 (14%) have results posted.
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National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
5 of the studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06796686National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health | 2027-01-15 |
| NCT06557785National Institute of Allergy and Infectious Diseases (NIAID)A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV | 2027-03-09 |
| NCT07342491National Institute of Allergy and Infectious Diseases (NIAID)Dasatinib for HIV-1 Reservoir Reduction | 2027-04-09 |
| NCT06508749National Institute of Allergy and Infectious Diseases (NIAID)The Tatelo Plus Study | 2027-09-03 |
| NCT06665646National Institute of Allergy and Infectious Diseases (NIAID)Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706 | 2027-11-30 |
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Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Concurrent Medication:
Allowed:
Consistently positive serum 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 p24 antigen test within 1 month of entry are excluded. Hemophiliacs are excluded.
Prior Medication:
Excluded within 4 weeks of study entry:
Prior Treatment:
Excluded within 2 weeks of study entry:
Severe diarrhea:
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent adequate compliance with study therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dextran Sulfate
National Institute of Allergy and Infectious Diseases (NIAID) →