A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide. SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden. A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
Key facts
- Study ID
- NCT00000812
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 36
- Expected to finish
- 2000-07-01
- Last updated by the study team
- 2021-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed for occasional use (chronic use is permitted only if clinician deems that medication can be discontinued in the event of overlapping toxicity):
- CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine), barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating antihistamines, or over-the-counter sleeping aids.
- Patients must have:
- HIV infection.
- CD4 count 200 - 500 cells/mm3.
- No active opportunistic infection requiring systemic therapy within the past 14 days.
- NOTE: Women must be post-menopausal or provide written documentation of surgical sterilization, and sexually active men must use a barrier method of contraception, beginning 4 weeks prior to study entry and continuing until 4 weeks following end of treatment.
- PER AMENDMENT 8/2/96:
- Been on stable licensed antiretroviral treatment for 60 days prior to study entry or must not have received any antiretroviral medications for 60 days prior to study entry.
- Prior Medication:
- Required:
- Patients must have been on stable licensed antiretroviral treatment for 60 days prior to study entry or must not have received any antiretroviral medications for 60 days prior to study entry.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy requiring chemotherapy.
- Grade 2 or worse peripheral neuropathy.
- Medical condition that would interfere with evaluation of patient.
- Concurrent Medication:
- Excluded in all patients:
- Didanosine ( ddI ).
- Zalcitabine ( ddC ).
- Stavudine ( d4T ).
- Other immunologically active agents.
- Systemic cytotoxic chemotherapy.
- Excluded in all patients unless taken only occasionally or unless medication could be stopped in the event of overlapping toxicity:
- CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine), barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating antihistamines, or over-the-counter sleeping aids.
- Patients with the following prior conditions are excluded:
- History of active tuberculosis within 3 months prior to study entry.
- History of intolerance to thalidomide such as fever, rash, or neuropathy.
- Prior Medication:
- Excluded within 14 days prior to study entry:
- Systemic chemotherapy.
- Excluded within 30 days prior to study entry:
- Topical, oral, and systemic corticosteroids.
- Pentoxifylline.
- Interferons.
- Interleukins.
Where it is running
- University of Colorado Hospital CRS — Aurora, Colorado, United States
- University of Minnesota, ACTU — Minneapolis, Minnesota, United States
- Memorial Sloan-Kettering Cancer Ctr. — New York, New York, United States
- Unc Aids Crs — Chapel Hill, North Carolina, United States
- Case CRS — Cleveland, Ohio, United States
- Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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