Completed

A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV

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What is being tested

Glycovir

+ Zidovudine
Drug
Who is being recruted

HIV Infections

Over 13 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens. SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection. SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection. Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.

Official TitleA Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 28, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
210 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Required: * PCP prophylaxis (trimethoprim/sulfamethoxazole, dapsone, or aerosolized pentamidine) in patients with CD4 count \<= 200 cells/mm3. Allowed: * Topical antifungal agents, ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections, as medically indicated. * Maintenance therapy for Mycobacteria disease with isoniazid, ethambutol, rifampin, pyrazinamide, clofazimine, ciprofloxacin, clarithromycin, or rifabutin. * Maintenance therapy for toxoplasmosis with pyrimethamine, sulfadiazine, or clindamycin. * Maintenance therapy for herpes simplex virus with acyclovir at \<= 1000 mg/day. * Recombinant erythropoietin and G-CSF, if indicated. * Antibiotics for bacterial infections. * Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics. Concurrent Treatment: Allowed: * Localized radiation therapy and limited intralesional therapy for cutaneous Kaposi's sarcoma. Patients must have: * Documented HIV infection. * Per 07/19/94 amendment, one of the following: * CD4 count 150 - 350 cells/mm3 within 60 days prior to study entry AND prior AZT for no more than 12 months cumulative (given with or without ddI or ddC). * CD4 count 50 - 350 cells/mm3 within 60 days prior to study entry AND no prior antiretroviral therapy. * MT-2 cell assay within 60 days prior to study entry. NOTE: * Minimal Kaposi's sarcoma is permitted. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: * Malignancy other than minimal Kaposi's sarcoma. Concurrent Medication: Excluded: * Antiretroviral therapies (other than study drug). * Biologic response modifiers. * Systemic corticosteroids for \> 21 consecutive days. * Foscarnet. * Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: * History of cataracts. * History of intolerance to AZT at \<= 600 mg/day. * Unexplained temperature \>= 38.5 degrees C that persists for any 7 days within the 30 days prior to study entry. * Chronic diarrhea (defined as \>= 3 stools per day) that persists for any 15 days within the 30 days prior to study entry. Prior Medication: Excluded: * More than 6 months (more than 12 months per 07/19/94 amendment) cumulative prior therapy with AZT. * Prior induction or maintenance therapy with foscarnet. * Any investigational drug within 30 days prior to study entry. * Prior SC-49483 or SC-48334. * Prior ddC, ddI, or stavudine (d4T) as monotherapy. * Interferon or interleukin within 30 days prior to study entry. * Prior non-nucleoside reverse transcriptase inhibitors (e.g., NVP, ATV). * Systemic corticosteroids for \> 21 consecutive days. * Acute treatment for a serious infection or any opportunistic infection within 14 days prior to study entry. * Prior combination therapy with AZT, ddI, and/or ddC within 30 days prior to study entry.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 22 locations
Suspended
Alabama Therapeutics CRSBirmingham, United StatesSee the location
Suspended
USC CRSLos Angeles, United States
Suspended
Stanford CRSPalo Alto, United States
Suspended
Ucsf Aids CrsSan Francisco, United States

Completed22 Study Centers