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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002001




Registration number
NCT00002001
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
24/06/2005

Titles & IDs
Public title
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
Scientific title
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
Secondary ID [1] 0 0
02
Secondary ID [2] 0 0
052B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zidovudine
Treatment: Drugs - Zalcitabine
Treatment: Drugs - Didanosine

Treatment: Drugs: Zidovudine


Treatment: Drugs: Zalcitabine


Treatment: Drugs: Didanosine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

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.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Saint Vincent's Hosp Med Centre - Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
Puerto Rico
State/province [4] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Glaxo Wellcome
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. To evaluate the safety and
the tolerance of the coadministration of zidovudine and ddI or ddC.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002001
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002001