HIV InfectionsPhase 2NCT00000791
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
A Phase 2 study testing Glycovir and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Glycovir and Zidovudine
- How many people
- 210 participants
- Where
- 22 sitesUnited States
- Study dates
- Start not givento Jul 1995
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Colorado Hospital CRS
Aurora, Colorado
Alabama Therapeutics CRS
Birmingham, Alabama
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14260
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Weiss Memorial Hosp.
Chicago, Illinois, 60640
Cook County Hosp. CORE Ctr.
Chicago, Illinois
Univ. of Cincinnati CRS
Cincinnati, Ohio
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana
Methodist Hosp. of Indiana
Indianapolis, Indiana
USC CRS
Los Angeles, California, 90033
Univ. of Miami AIDS CRS
Miami, Florida
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York
Stanford CRS
Palo Alto, California
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania
Wake County Health and Human Services CRS
Raleigh, North Carolina
Univ. of Rochester ACTG CRS
Rochester, New York
Ucsf Aids Crs
San Francisco, California, 94110
University of Washington AIDS CRS
Seattle, Washington, 98104
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
About this study
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Glycovir, Zidovudine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycovirDrug
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)
- Study completionJul 1995
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Enrolment
- 210 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- G D Searle, Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- Fischl MA, Study chairSaag M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000791
- Sponsor's protocol ID
- ACTG 259
- Other IDs
- 11236
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
Johnson VA, Bassett RL, Stanley KE, Saag MS, Fischl MA. Predictors of syncytium-inducing viral phenotype in a phase II double-blind trial of SC-49483 plus ZDV vs. ZDV. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:102 (abstract no 205)
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
- ClinicalTrials.gov ID
- NCT00000791
- Acronym / sponsor ID
- ACTG 259
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- G D Searle, Glaxo Wellcome
- Study completion
- Jul 1995 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- PCP prophylaxis (trimethoprim/sulfamethoxazole, dapsone, or aerosolized pentamidine) in patients with CD4 count <= 200 cells/mm3.
- 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.
Key exclusion criteria (27 listed)
- Malignancy other than minimal Kaposi's sarcoma.
- Antiretroviral therapies (other than study drug).
- Biologic response modifiers.
- Systemic corticosteroids for > 21 consecutive days.
- Foscarnet.
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 |
|---|---|---|
| Glycovir | 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 28 Oct 2021.
- BackgroundJohnson VA, Bassett RL, Stanley KE, Saag MS, Fischl MA. Predictors of syncytium-inducing viral phenotype in a phase II double-blind trial of SC-49483 plus ZDV vs. ZDV. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:102 (abstract no 205)
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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.
Fischl MA study chair
Saag M study chair
22 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 Glycovir and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 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 22 inclusion and 27 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 NCT00000791, 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 28 Oct 2021; AzTrials last refreshed its copy on 4 Nov 2026.