HIV InfectionsPhase 2NCT00002151
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
A Phase 2 study testing Celgosivir hydrochloride in people with HIV Infections, run by Hoechst Marion Roussel at 24 sites in United States.
Trial summary
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. 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?
- Celgosivir hydrochloride
- How many people
- 200 participants
- Where
- 24 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:
- Prior antiretroviral agents for up to 6 months per agent.
- Patients must have:
- HIV infection.
- Asymptomatic or mildly symptomatic.
- CD4 count 301 - 500 cells/mm3.
Who cannot join
- Co-existing Condition:
- Patients with the following condition are excluded:
- Unable or unwilling to comply with study procedures.
- Concurrent Medication:
- Excluded:
- Chemoprophylactic therapy for mycobacterial infection.
Show all 21Show fewer
- Any nonstudy prescription medications without approval of investigator.
- Patients with the following prior conditions are excluded:
- History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
- History of intolerance to lactose.
- Chronic diarrhea within 6 months prior to study entry.
- Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
- Prior Medication:
- Excluded:
- Antiretroviral therapy within 2 weeks prior to study entry.
- Prior HIV vaccines.
- Biological response modifiers within 30 days prior to study entry.
- Prior foscarnet.
- Any investigational drug with a washout < 5 half-lives prior to study entry.
- Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.
- Recent history of alcohol and/or drug abuse.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
California Clinical Trials Med Group
Beverly Hills, California, 90211
Ctr for Special Immunology
Chicago, Illinois, 60657
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103
Univ Health Ctr
Detroit, Michigan, 48201
Independent Investigator
Fort Lauderdale, Florida, 33316
North Broward Hosp District
Fort Lauderdale, Florida, 33316
Univ TX Galveston Med Branch
Galveston, Texas, 775550835
Houston Clinical Research Network
Houston, Texas, 77006
Antibiotic Research Associates
Kansas City, Missouri, 64132
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90027
Clinical Investigations Health Services
Mobile, Alabama, 366880002
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, 70112
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Community Health Network
Rochester, New York, 14620
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Clinical Research Ctr
Sarasota, Florida, 34239
Guthrie Clinic
Sayre, Pennsylvania, 18840
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Infectious Disease Associates
Toledo, Ohio, 43608
Independent Investigator
Vero Beach, Florida, 32960
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
- Conditions
- HIV Infections
- Being tested
- Celgosivir hydrochloride
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, MDL 28574
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celgosivir hydrochlorideDrug
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.
- 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
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hoechst Marion Roussel
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002151
- Sponsor's protocol ID
- 221C
- Other IDs
- 028574PR0004, NDPR0004
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002151
- Acronym / sponsor ID
- 221C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, MDL 28574
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Hoechst Marion RousselIndustry (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.
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prior antiretroviral agents for up to 6 months per agent.
- HIV infection.
- Asymptomatic or mildly symptomatic.
- CD4 count 301 - 500 cells/mm3.
Key exclusion criteria (21 listed)
- Unable or unwilling to comply with study procedures.
- Chemoprophylactic therapy for mycobacterial infection.
- Any nonstudy prescription medications without approval of investigator.
- History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
- History of intolerance to lactose.
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 |
|---|---|---|
| Celgosivir hydrochloride | 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.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
24 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 Celgosivir hydrochloride in people with HIV Infections, run by Hoechst Marion Roussel at 24 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 7 inclusion and 21 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 24 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?
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.