Search / Trial NCT00002365

A Study of LXR015-1 in HIV-Infected Patients

Launched by LXR BIOTECHNOLOGY · Aug 30, 2001

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Dose Response Relationship, Drug Administration, Oral Acquired Immunodeficiency Syndrome Anti Hiv Agents

ClinConnect Summary

Patients will be randomized to 1 of 3 doses of oral LXR015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. Patients will continue to be monitored for least 4 weeks after completion of the dosing.

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Patients must have:
  • • Documented HIV infection.
  • • CD4 cell count less than 200 cells/mm3.
  • 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:
  • • Patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort).
  • • Patients who have severe diarrhea as defined as \>= 7 stools per day, or acute diarrhea due to a treatable cause.
  • NOTE:
  • • If the patient has Cryptosporidia, Mycobacterium avium, or Cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study.
  • • Patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks.
  • • Patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious AIDS defining infections requiring immediate treatment. Acute therapy must be completed at least 28 days before study entry.
  • • Patients with unexplained elevated temperature \>= 38.5 degrees C that persists for 7 days or more within 14 days before study entry.
  • • Patients with malignancy other than squamous or basal carcinomas of the skin. Patients with visceral Kaposi's sarcoma or lymphoma requiring systemic chemotherapy or radiation treatment will be excluded. Patients with Kaposi's of the skin or mucous membranes may enroll in this study.
  • • Patients, who in the judgment of the investigator are unable to comply with the protocol.
  • 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:
  • • This hypersensitivity is identified through medical history, not skin testing.
  • Excluded:
  • • Systemic chemotherapy.
  • • Acute therapy for opportunistic infections or other serious AIDS defining infections.
  • • Intravenous rehydration as treatment for diarrhea.
  • 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.

Trial Officials

Bathurst I

Study Chair

About Lxr Biotechnology

LXR Biotechnology is a pioneering biopharmaceutical company focused on the discovery and development of innovative therapeutics for the treatment of metabolic and inflammatory diseases. Leveraging advanced molecular biology and cutting-edge drug design techniques, LXR Biotechnology aims to address unmet medical needs through its proprietary platforms and a robust pipeline of drug candidates. Committed to scientific excellence and patient-centric solutions, the company collaborates with leading research institutions and industry partners to translate groundbreaking research into effective therapies, ultimately enhancing patient outcomes and improving quality of life.

Locations

Berkeley, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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