## Protocol Section
### Identification Module
**NCT ID:** NCT00002079

**Brief Title:** 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)

**Official Title:** 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)

#### Organization Study ID Info
**ID:** 057B
#### Organization
**Class:** INDUSTRY
**Full Name:** NIH AIDS Clinical Trials Information Service
#### Secondary ID Infos
**ID:** NS8-91-02-009
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2005-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2005-06-23

**Overall Status:** COMPLETED

**Status Verified Date:** 1993-03

#### Study First Post Date
**Date:** 2001-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-02
**Study First Submit QC Date:** 2001-08-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** G D Searle

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- HIV Infections

**Keywords:**

- Zidovudine

- 1-Deoxynojirimycin

### Design Module

#### Design Info

**Primary Purpose:** TREATMENT

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Butyldeoxynojirimycin

**Type:** DRUG

#### Intervention 2

**Name:** Zidovudine

**Type:** DRUG

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count 200 - 500 cells/mm3.
* Prior therapy with 12 - 48 weeks of AZT.

Exclusion Criteria

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:

Whole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** Dr Marcus Conant

**State:** California

**Zip:** 94115

**Location 2:**

**City:** Tarzana

**Country:** United States

**Facility:** Shared Med Research Foundation

**State:** California

**Zip:** 91356

**Location 3:**

**City:** Miami Beach

**Country:** United States

**Facility:** Stratogen of South Florida

**State:** Florida

**Zip:** 33140

**Location 4:**

**City:** Tampa

**Country:** United States

**Facility:** Saint Joseph's Hosp / Infectious Disease Rsch Institute

**State:** Florida

**Zip:** 33614

**Location 5:**

**City:** Atlanta

**Country:** United States

**Facility:** West Paces Clinical Research Incoporated

**State:** Georgia

**Zip:** 30327

**Location 6:**

**City:** Pittsburgh

**Country:** United States

**Facility:** Dr Samuel W Golden

**State:** Pennsylvania

**Zip:** 15218

**Location 7:**

**City:** Dallas

**Country:** United States

**Facility:** Dallas Veterans Administration Med Ctr

**State:** Texas

**Zip:** 75216

**Location 8:**

**City:** Fort Worth

**Country:** United States

**Facility:** Dr Daniel Barbero

**State:** Texas

**Zip:** 76104

**Location 9:**

**City:** Houston

**Country:** United States

**Facility:** Park Plaza Hosp

**State:** Texas

**Zip:** 77004

### References Module

#### References

**Citation:** 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.

**PMID:** 7905523

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018894

- Term: Reverse Transcriptase Inhibitors

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000065089

- Term: Glycoside Hydrolase Inhibitors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M351060

- Name: Miglustat

- Relevance: HIGH

- As Found: ACG

- ID: M17920

- Name: Zidovudine

- Relevance: HIGH

- As Found: Intraoperative

- ID: M19750

- Name: 1-Deoxynojirimycin

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M20935

- Name: Reverse Transcriptase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5557

- Name: Cardiac Glycosides

- Relevance: LOW

- As Found: Unknown

- ID: M30447

- Name: Glycoside Hydrolase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000059896

- Term: Miglustat

- ID: D000015215

- Term: Zidovudine

### Misc Info Module

- Version Holder: 2024-05-24
