HIV InfectionsPhase 1NCT00000806
A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
A Phase 1 study testing Telinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151. SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Telinavir
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Required for patients with CD4 count <= 200 cells/mm3:
- PCP prophylaxis using TMP/SMX or aerosolized pentamidine.
- Allowed:
- Topical antifungal agents.
- Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.
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- Antibiotics for bacterial infections.
- Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.
- Patients must have:
- HIV infection.
- CD4 count 150 - 500 cells/mm3.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Unable to tolerate the standard diet required for the study.
- Unable to give informed consent.
- Concurrent Medication:
- Excluded:
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- Antiretrovirals and biologic response modifiers (including HIV vaccines).
- Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
- Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
- Allopurinol.
- Omeprazole.
- Astemizole.
- Terfenadine.
- Loratadine.
- Psychotropics.
- Phenylbutazone.
- Barbiturates.
- Benzodiazepines.
- Monoamine oxidase inhibitors.
- H-2 blockers.
- Anticonvulsants.
- Coumadin anticoagulants.
- Oral contraceptives.
- Antiarrhythmics.
- Diltiazem.
- Metronidazole.
- Erythromycin.
- Chloramphenicol.
- Fluoroquinolones.
- Disulfiram.
- Erythropoietin.
- G-CSF or GM-CSF.
- Systemic corticosteroids.
- Alcohol, including alcohol-containing medications.
- Patients with the following prior conditions are excluded:
- Unexplained temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
- Chronic diarrhea (>= three stools per day) for any 15 days within the 30 days prior to study entry.
- Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.
- Prior Medication:
- Excluded at any time:
- Prior HIV protease inhibitor.
- Excluded within 30 days prior to study entry:
- Investigational drugs.
- Recombinant erythropoietin.
- G-CSF or GM-CSF.
- Interferon or interleukin.
- Any HIV-1 vaccine.
- Excluded within 14 days prior to study entry:
- Antiretrovirals.
- Acute therapy for any opportunistic or other serious infection.
- Therapy for malignancy.
- Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
- Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
- Excluded within 7 days prior to study entry:
- Allopurinol.
- Omeprazole.
- Astemizole.
- Terfenadine.
- Loratadine.
- Psychotropics.
- Phenylbutazone.
- Barbiturates.
- Benzodiazepines.
- Monoamine oxidase inhibitors.
- H-2 blockers.
- Anticonvulsants.
- Coumadin anticoagulants.
- Oral contraceptives.
- Antiarrhythmics.
- Diltiazem.
- Metronidazole.
- Erythromycin.
- Chloramphenicol.
- Fluoroquinolones.
- Disulfiram.
- Risk Behavior: Excluded:
- History of substance or alcohol abuse.
- Ingestion of more than 50 g alcohol daily within 6 months prior to study entry.
- Recovered alcoholic.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Miami School of Medicine
Miami, Florida, 331361013
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
About this study
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.
SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity.
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Read the detailed description
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.
- Conditions
- HIV Infections
- Being tested
- Telinavir
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors
- 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.
TelinavirDrug
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 48 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Fischl MA, Study chairRichman DD, Study chairFlexner C, Study chairPara MF, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000806
- Sponsor's protocol ID
- ACTG 282
- Status last verified
- Feb 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Fischl MA, Richman DD, Flexner C, Meehan P, Para MF, Haubrich R, Cook J, Wood K, Karim A. Phase I study of two formulations and dose schedules of SC- 521151, A protease inhibitor. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:88
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
- A Phase I Randomized Dose/Formulation Comparison Study of SC-52151
- ClinicalTrials.gov ID
- NCT00000806
- Acronym / sponsor ID
- ACTG 282
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Protease Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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.
PRIMARY: To evaluate the safety, tolerability, pharmacokinetics, and ethanol exposure of two dose regimens and formulations of SC-52151.
SECONDARY: To evaluate the preliminary anti-HIV activity of these treatment regimens and the relationship between day 14 plasma concentrations of SC-52151 and immunological and virological markers and toxicity.
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Detailed description
Since viral isolates with decreased susceptibility to the protease inhibitor SC-52151 occur in vitro after multiple passages, and since prolonged post infectious effects occur in vitro, comparison of two formulations, an elixir and a self-emulsifying drug delivery system (SEDDS), is needed to determine the appropriate dose formulation for Phase II studies.
Patients are randomized to four treatment arms to receive SC-52151 elixir or SEDDS formulation at 1 of 2 doses for 2 weeks, with follow-up for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- PCP prophylaxis using TMP/SMX or aerosolized pentamidine.
- Topical antifungal agents.
- Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.
- Antibiotics for bacterial infections.
- Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.
Key exclusion criteria (79 listed)
- Unable to tolerate the standard diet required for the study.
- Unable to give informed consent.
- Antiretrovirals and biologic response modifiers (including HIV vaccines).
- Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
- Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
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 |
|---|---|---|
| Telinavir | 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.
- BackgroundFischl MA, Richman DD, Flexner C, Meehan P, Para MF, Haubrich R, Cook J, Wood K, Karim A. Phase I study of two formulations and dose schedules of SC- 521151, A protease inhibitor. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:88
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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
Richman DD study chair
Flexner C study chair
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 11 inclusion and 79 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 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT00000806, 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; AzTrials last refreshed its copy on 31 Oct 2026.