HIV InfectionsNCT00002001
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
A study testing Zidovudine, Zalcitabine and Didanosine in people with HIV Infections, run by Glaxo Wellcome at 5 sites in 3 countries.
Trial summary
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. 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?
- Zidovudine, Zalcitabine and Didanosine
- How many people
- Not given
- Where
- 5 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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:
- Allowed:
- Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm.
- Prophylaxis for PCP.
- Patients must have the following:
- HIV-1 seropositive by any federally licensed ELISA.
- Willingness to give informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Any immediately life-threatening infection or medical condition present at time of study entry.
- Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
- Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
- Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy.
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- AIDS dementia complex, > or = Stage 2.
- History of zidovudine induced toxicity.
- Prior history of acute pancreatitis during the past two years or chronic pancreatitis.
- Grade 2 neuropathy.
- Intractable diarrhea.
- History of seizures within the past six months or current requirement of anticonvulsants.
- Past or current heart disease.
- Fever > 39 C at entry.
- Concurrent Medication:
- Current requirement of anticonvulsants.
- Excluded:
- It is intended that patients developing new opportunistic infections during the course of the study will continue study participation, unless required therapy is associated with significant neurologic or hematologic toxicities, in which case the study medication may be temporarily discontinued.
- Ganciclovir.
- Chloramphenicol.
- Cisplatinum.
- Iodoquinol.
- Systemic Pentamidine.
- Disulfiram.
- Ethionamide.
- Glutethimide.
- Gold.
- Hydralazine.
- Metronidazole.
- Sodium Cyanate.
- Thalidomide.
- Vincristine.
- Allopurinol.
- Probenecid.
- Concurrent Treatment:
- Excluded:
- Radiation therapy. (with the exception of electron beam therapy to an area of < 100cm/m2.)
- Patients with the following are excluded:
- Any immediately life-threatening infection or medical condition present at time of study entry.
- Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
- Active alcohol or drug abuse, sufficient in the investigator's opinion to prevent compliance with study therapy.
- Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
- Kaposi's syndrome with visceral involvement or requiring systemic cytotoxic chemotherapy.
- AIDS dementia complex, > or = Stage 2.
- History of zidovudine induced toxicity.
- Any experimental therapy within 30 days.
- Prior history of acute pancreatitis during the past two years or chronic pancreatitis.
- Grade 2 neuropathy.
- Intractable diarrhea.
- History of seizures within the past six months or current requirement of anticonvulsants.
- History of past or current heart disease.
- Fever > 39 C at entry.
- Prior Medication:
- Excluded:
- Any anti-HIV therapy (other than zidovudine), biologic response modifiers, or pharmacologic doses of corticosteroids within eight weeks of entry (except for the management of severe PCP, in which case duration is not to exceed 21 days).
- Zidovudine therapy for greater than four weeks or prior discontinuation due to drug toxicity.
- Prior therapy with ddI, ddC, D4T, or interferon.
- Any experimental therapy within 30 days.
- Therapy within 30 days with neurotoxic drugs.
- Prior Treatment:
- Excluded:
- Radiation therapy within two weeks of entry or likely to require radiation therapy (with the exception of electron beam therapy to an area of < 100cm/m2).
- Active alcohol or drug abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Vanderbilt School of Medicine
Nashville, Tennessee, 37232
Georgetown Univ Med Ctr / Main Hosp 4
Washington D.C., District of Columbia, 20007
Puerto Rico1 site
San Juan Veterans Administration Med Ctr
San Juan, 009275800
About this study
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Zalcitabine, Didanosine
- Keywords
- Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
ZalcitabineDrug
DidanosineDrug
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.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002001
- Sponsor's protocol ID
- 052B
- Other IDs
- 02
- Status last verified
- Sep 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Larder BA, Kohli A, Bloor S, Kemp SD, Harrigan PR, Schooley RT, Lange JM, Pennington KN, St Clair MH. Human immunodeficiency virus type 1 drug susceptibility during zidovudine (AZT) monotherapy compared with AZT plus 2',3'-dideoxyinosine or AZT plus 2',3'-dideoxycytidine combination therapy. The protocol 34,225-02 Collaborative Group. J Virol. 1996 Sep;70(9):5922-9. doi: 10.1128/JVI.70.9.5922-5929.1996.
PubMed 8709213
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
- The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
- ClinicalTrials.gov ID
- NCT00002001
- Acronym / sponsor ID
- 052B
- Conditions
- HIV Infections
- Keywords
- Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (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 evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.
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 (7 listed)
- Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm.
- Prophylaxis for PCP.
- HIV-1 seropositive by any federally licensed ELISA.
- Willingness to give informed consent.
Key exclusion criteria (63 listed)
- Any immediately life-threatening infection or medical condition present at time of study entry.
- Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section.
- Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix.
- Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy.
- AIDS dementia complex, > or = Stage 2.
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 | – |
| Didanosine | 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.
- Background: PubMed 8709213Larder BA, Kohli A, Bloor S, Kemp SD, Harrigan PR, Schooley RT, Lange JM, Pennington KN, St Clair MH. Human immunodeficiency virus type 1 drug susceptibility during zidovudine (AZT) monotherapy compared with AZT plus 2',3'-dideoxyinosine or AZT plus 2',3'-dideoxycytidine combination therapy. The protocol 34,225-02 Collaborative Group. J Virol. 1996 Sep;70(9):5922-9. doi: 10.1128/JVI.70.9.5922-5929.1996.
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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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine, Zalcitabine and Didanosine in people with HIV Infections, run by Glaxo Wellcome at 5 sites in 3 countries.
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 63 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 5 sites in United States, Australia, Puerto Rico. 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.
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 NCT00002001, 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.