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

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Celgene

Status and phase

Completed
Phase 2

Conditions

HIV Wasting Syndrome
HIV Infections

Treatments

Drug: Thalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002127
W-001
230A

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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