Clinical trial NCT00002127: A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Official title: A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
HIV Wasting Syndrome
Keywords: Acquired Immunodeficiency Syndrome
Cachexia
Thalidomide
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

Detailed description: Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
* Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).

Patients must have:

* Documented HIV infection.
* Wasting syndrome.
* Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
* No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
* Life expectancy of at least 6 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Chronic diarrhea (five or more unformed stools per day).
* Peripheral neuropathy of grade 2 or worse.
* Requirement for tube feeding or intravenous feeding.
* Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
* Inability to ingest at least a maintenance diet based on present weight.
* Any condition that precludes study participation.
* Not under the care of a primary physician.

Concurrent Medication:

Excluded:

* Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).

Concurrent Treatment:

Excluded:

* Radiotherapy.

Patients with the following prior conditions are excluded:

* Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.
* Prior intolerance to thalidomide.

Prior Medication:

Excluded:

* ddC within 1 month prior to study entry.
* Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
* Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.

Prior Treatment:

Excluded:

* Radiotherapy within 6 weeks prior to study entry.

Required ONLY IF patient is on antiretroviral therapy:

* Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Marin County Specialty Clinic
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr - Owen Clinic
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: Sherman Oaks
country: United States
facility: Gottlieb Med Group
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: Newark
country: United States
facility: Saint Michael's Med Ctr
state: New Jersey
city: New York
country: United States
facility: Rockefeller Univ
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson Med College
state: Pennsylvania
city: Seattle
country: United States
facility: Advanced Research Management
state: Washington
Study officials:
References:
citation: Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.