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NCT00251537
A Pilot Study Assessing Safety and Antiretroviral Activity of Intravenously Administered LTB4 in HIV-1 Infected Adults With a CD4 Count Greater Than 250 Cells/mm3 and a Viral Load Greater Than 5,000 Copies/mL, and Who Have Not Received Antiretroviral Therapy Within Two Months
Phase 2 trial testing LTB4 in HIV Infections in 40 participants. Completed in 1 August 2006.
Quick facts
| Lead sponsor | LTB4 Sweden AB |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2005 |
| Estimated completion | 1 August 2006 |
| Sites | 7 locations across Canada |
Drugs / interventions tested
- LTB4 — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
LTB4 Sweden AB — full company profile →
Who can join
Adults 18 to 65, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To assess the effect of 28 days of daily dosing of LTB4 on HIV viral load
Sponsor's own description
This is a pilot study to assess the safety and antiretroviral activity of a naturally occuring substance known as Leukotriene B4(LTB4). The aim of the study is to determine the effect of LTB4 on viral load during a period of 6 weeks, 4 weeks of active treatment and 2 additional weeks after the end of active treatment for safety follow-up. 40 patients in seven clinics in Canada will be randomized into three treatment arms, either of two doses of LTB4 or placebo. Study drug is administered intravenously once daily. LTB4 can activate and stimulate various white blood cells and by the activation release natural substances in the body and this process is an important part of the body's defense against infections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00251537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00251537 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LTB4 Sweden AB
- Last refreshed: 7 July 2006
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00251537.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing