A Study of LXR015-1 in HIV-Infected Patients

NCT00002365 | Completed Phase 1

• 1 other identifier: 258A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.

Conditions

HIV Infections

Keywords

Dose-Response Relationship, Drug; Administration, Oral; Acquired Immunodeficiency Syndrome; Anti-HIV Agents

Interventions

LXR015-1 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• LXR Biotechnology: lead

Study Sites (1)

East Bay AIDS Ctr

Berkeley, California, 94705, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Bathurst I

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-07

Locations

US (1)