Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)
Completed · Phase 2
Conditions studied: HIV Infections
In brief
To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.
Key facts
- Study ID
- NCT00002079
- Run by
- G D Searle
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- Documented HIV infection.
- CD4 cell count 200 - 500 cells/mm3.
- Prior therapy with 12 - 48 weeks of AZT.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinically significant diarrhea without definable cause (> 3 liquid stools per day for more than 7 days within 6 months prior to study entry).
- Diarrhea, as above, with known non-HIV-related cause occurring within 1 month prior to study entry.
- Symptoms meeting CDC criteria for AIDS classification.
- Fever as a constitutional sign of HIV disease (> 38.5 degrees C persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry).
- Malignancies, other than basal cell carcinoma and Kaposi's sarcoma (provided patient has fewer than 10 Kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment).
- Significant organ dysfunction.
- Known hypersensitivity to SC-48334 or AZT or related compounds.
- Concurrent Medication:
- Excluded:
- Any investigational drug other than SC-48334.
- Any anti-HIV drug other than AZT.
- Cancer chemotherapy.
- Patients with the following prior conditions are excluded:
- History of cataracts or known increased risk of cataract formation.
- Known hypersensitivity to SC-48334 or AZT or related compounds.
- History of lactose intolerance.
- Prior Medication:
- Excluded:
- Prior SC-48334.
- Cancer chemotherapy within 6 months prior to study entry.
- Treatment with any investigational drug or any drug with anti-HIV activity, other than AZT, within 30 days prior to study entry.
- Prior Treatment:
- Excluded:
Where it is running
- Dr Marcus Conant — San Francisco, California, United States
- Shared Med Research Foundation — Tarzana, California, United States
- Stratogen of South Florida — Miami Beach, Florida, United States
- Saint Joseph's Hosp / Infectious Disease Rsch Institute — Tampa, Florida, United States
- West Paces Clinical Research Incoporated — Atlanta, Georgia, United States
- Dr Samuel W Golden — Pittsburgh, Pennsylvania, United States
- Dallas Veterans Administration Med Ctr — Dallas, Texas, United States
- Dr Daniel Barbero — Fort Worth, Texas, United States
- Park Plaza Hosp — Houston, Texas, United States
Full record on ClinicalTrials.gov
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