Clinical trial NCT00002365: A Study of LXR015-1 in HIV-Infected Patients
Official title: A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Administration, Oral
Acquired Immunodeficiency Syndrome
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
Study officials:
name: Bathurst I
role: STUDY_CHAIR
References: