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Sponsored by: |
LXR Biotechnology |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002365 |
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: LXR015-1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Acute therapy for opportunistic infections or serious AIDS defining infections must be completed at least 28 days before study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
NOTE:
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior condition are excluded:
A known history of hypersensitivity reaction to soy protein or soy lecithin. NOTE:
Excluded:
Required:
Patient must be taking a stable regimen (about 8 weeks) of anti-viral, anti-opportunistic infection and/or anti-diarrheal (if patient has diarrhea) medications.
Study ID Numbers: | 258A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002365 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dose-Response Relationship, Drug Administration, Oral Acquired Immunodeficiency Syndrome Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |