To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected
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.
Patients must have:
- Documented HIV infection.
- CD4 cell count less than 200 cells/mm3.
Acute therapy for opportunistic infections or serious AIDS defining infections must be
completed at least 28 days before study entry.
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
- Patients who have severe diarrhea as defined as >= 7 stools per day, or acute
diarrhea due to a treatable cause.
- 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
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.
- Systemic chemotherapy.
- Acute therapy for opportunistic infections or other serious AIDS defining infections.
- Intravenous rehydration as treatment for diarrhea.
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.