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A Study of LXR015-1 in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002365
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002365


Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Sponsors and Collaborators
LXR Biotechnology
Investigators
Study Chair: Bathurst I
  More Information

ClinicalTrials.gov Identifier: NCT00002365     History of Changes
Other Study ID Numbers: 258A
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: July 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
Administration, Oral
Acquired Immunodeficiency Syndrome
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases