Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

T

The Searle Company

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: Zidovudine
Drug: Butyldeoxynojirimycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00001993
NS8-90-02-004
057A

Details and patient eligibility

About

The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3. The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Medications for the prophylaxis of opportunistic infections, such as:
  • Aerosolized pentamidine.
  • Trimethoprim/sulfamethoxazole.
  • Nystatin.
  • Clotrimazole.
  • Anti-mycobacterial agents.
  • Ganciclovir.
  • Topical acyclovir.

Patients must have the following:

  • CD4+ cells counts = or > 200 < 500 /cell mm3.
  • For purposes of inclusion the absolute CD4+ cell count must be = or > 200 < 500 cells/mm3 on the first sample and = or > 190 < 510 cells/mm3 on the second sample.
  • Have at least one of the following:
  • Oral candidiasis.
  • Herpes zoster during the last 3 years.
  • Oral hairy leukoplakia during the past three years.
  • Chronic ( > 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).
  • Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.
  • Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.
  • HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).
  • Documented, written informed consent must be obtained prior to admission to the study.

Prior Medication:

Allowed for no more than 12 weeks prior to study entry:

  • Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.

Concurrent Medication:

Excluded:

  • All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.
  • Anti-metabolites and alkylating agents.
  • All investigational non-FDA approved drugs.

Patients with the following are excluded:

  • Clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause, within 6 months prior to enrollment).
  • Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.
  • Meets CDC criteria for AIDS classification.
  • Chronic fever (> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).
  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.
  • Known hypersensitivity to SC-48334 or related compounds.
  • History of lactose intolerance.

Prior Medication:

Excluded within 30 days of study entry:

  • Any investigational medication.
  • Treatment with a drug (other than Zidovudine) with anti-HIV activity.
  • Excluded for > 12 weeks prior to study entry:
  • Zidovudine (AZT).
  • Excluded within 90 days of study entry:
  • Ribavirin.
  • Excluded within 6 months of study entry:
  • Cancer chemotherapy.
  • Excluded:
  • Treatment with SC-48334.

Prior Treatment:

Excluded within 30 days of study entry:

  • Electron beam radiation.
  • Excluded within 6 months prior to study entry:
  • Required HIV-related blood transfusions.
  • Whole body radiation.

Current use of illicit substances; or current abuse of alcohol, the use of which would limit compliance with the protocol.

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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