A Study of LXR015-1 in HIV-Infected Patients
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 discomfort).
- 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 protocol.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002365
|East Bay AIDS Ctr
|Berkeley, California, United States, 94705 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 21, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases