A Study of LXR015-1 in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002365
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
  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: Endpoint Classification: Safety Study
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00002365     History of Changes
Other Study ID Numbers: 258A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014