A Study of LXR015-1 in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00002365

Run by

LXR Biotechnology

People needed

30

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States

Full record on ClinicalTrials.gov

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