HIV InfectionsPhase 2NCT00001993
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
A Phase 2 study testing Butyldeoxynojirimycin and Zidovudine in people with HIV Infections, run by G D Searle at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Butyldeoxynojirimycin and Zidovudine
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Medications for the prophylaxis of opportunistic infections, such as:
- Aerosolized pentamidine.
- Trimethoprim/sulfamethoxazole.
- Nystatin.
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- 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).
Who cannot join
- 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:
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of Washington
Seattle, Washington, 981224304
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Butyldeoxynojirimycin, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButyldeoxynojirimycinDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- G D Searle
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001993
- Sponsor's protocol ID
- 057A
- Other IDs
- NS8-90-02-004
- Status last verified
- Feb 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Fischl MA, Resnick L, Coombs R, Kremer AB, Pottage JC Jr, Fass RJ, Fife KH, Powderly WG, Collier AC, Aspinall RL, et al. The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3. J Acquir Immune Defic Syndr (1988). 1994 Feb;7(2):139-47.
PubMed 7905523
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00001993
- Acronym / sponsor ID
- 057A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- G D SearleIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Medications for the prophylaxis of opportunistic infections, such as:
- Aerosolized pentamidine.
- Trimethoprim/sulfamethoxazole.
- Nystatin.
- Clotrimazole.
Key exclusion criteria (37 listed)
- Malignancies, with the exception of basal cell carcinoma.
- Significant organ dysfunction.
- All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.
- Anti-metabolites and alkylating agents.
- All investigational non-FDA approved drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butyldeoxynojirimycin | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 7905523Fischl MA, Resnick L, Coombs R, Kremer AB, Pottage JC Jr, Fass RJ, Fife KH, Powderly WG, Collier AC, Aspinall RL, et al. The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3. J Acquir Immune Defic Syndr (1988). 1994 Feb;7(2):139-47.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Butyldeoxynojirimycin and Zidovudine in people with HIV Infections, run by G D Searle at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.