HIV InfectionsPhase 3NCT00002117
A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
A Phase 3 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 24 sites in United States.
Trial summary
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with 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?
- Zidovudine and Zalcitabine
- How many people
- 528 participants
- Where
- 24 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Patients must have:
- HIV infection.
- CD4 count 100 - 500 cells/mm3.
Who cannot join
None listed.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
Intergrated Care Ctr
Atlanta, Georgia, 30327
New England Med Ctr
Boston, Massachusetts, 02111
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Denver Public Health Dept / Disease Control Services
Denver, Colorado, 80204
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
Kaiser Foundation Hosp
Harbor City, California, 90710
Kaiser Permanente Med Ctr
Los Angeles, California, 90027
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Univ of Miami School of Medicine
Miami, Florida, 33136
Dr Brian Buggy
Milwaukee, Wisconsin, 53215
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Oregon Health Sciences Univ
Portland, Oregon, 97201
St Paul Ramsey Med Ctr / HIV Program Office
Saint Paul, Minnesota, 55101
Sharp Rees - Stealy Med Group
San Diego, California, 92101
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Washington Univ
St Louis, Missouri, 63110
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468
Howard Univ
Washington D.C., District of Columbia, 20060
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.
Read the detailed description
Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Zalcitabine
- Keywords
- Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, 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.
ZidovudineDrug
ZalcitabineDrug
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.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Enrolment
- 528 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002117
- Sponsor's protocol ID
- 220A
- Other IDs
- NV 14257
- Status last verified
- Feb 1995
- 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, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00002117
- Acronym / sponsor ID
- 220A
- Conditions
- HIV Infections
- Keywords
- Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (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 investigate the appropriate zalcitabine ( dideoxycytidine; ddC ) dose and zidovudine ( AZT ) schedule for use in combination therapy in patients with HIV infection.
Detailed description
Patients are randomized to one of four treatment arms. ddC is administered at 1 of 2 doses every 8 hours. AZT is administered at 1 of 2 doses (every 4 hours while awake or every 8 hours).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infection.
- CD4 count 100 - 500 cells/mm3.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Zidovudine | Drug | – |
| Zalcitabine | 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.
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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.
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 3 study testing Zidovudine and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche 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 3 inclusion and 0 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.