HIV InfectionsPhase 1NCT00002014
A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)
A Phase 1 study testing Zidovudine and Didanosine in people with HIV Infections, run by Glaxo Wellcome at 4 sites in United States.
Trial summary
To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently. 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 Didanosine
- How many people
- Not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Acyclovir not to exceed two 14-day courses of therapy during trial. Discontinue ddI while receiving acyclovir.
- Patients must have the following:
- Positive HIV antibody using federally licensed ELISA test kit.
- CD4 counts < 400 on two consecutive visits within one month prior to entry.
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- Prior Medication:
- Allowed:
- Zidovudine (AZT) if treated for less than 120 days.
- Pharmacologic doses of steroids if given for management of Pneumocystis carinii pneumonia (PCP) (not to exceed 21 days).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the thirty days prior to entry) or patients who require chemotherapy or radiation therapy for Kaposi's sarcoma. Other concurrent neoplasms other than basal cell carcinoma of skin or in situ carcinoma of the cervix. Malabsorption as defined by persistent diarrhea ( > 4 stools/day for four weeks) which is unresponsive to antidiarrheal agents. Opportunistic infection requiring maintenance therapy. History of Central Nervous System opportunistic infections (e.g., toxoplasmosis, cryptococcosis). History of seizure disorders. Prior history of pancreatitis. History of peripheral neuropathy or any significant signs or symptoms of neurological disease. Examinations for peripheral neuropathy should assess changes in extremities. Clinically significant hyperuricemia (tophaceous gout, urate nephropathy). History of cardiomyopathy.
- Concurrent Medication:
- Excluded:
- Intravenous pentamidine.
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- Intravenous trimethoprim / sulfamethoxazole.
- Alcohol.
- Suppressive acyclovir therapy (see Inclusion Medications).
- Allopurinol.
- Probenecid.
- Isoniazid (INH).
- Dipyridamole.
- Concurrent Treatment:
- Excluded:
- Radiation therapy for Kaposi's sarcoma.
- Patients with the following are excluded:
- Zidovudine (AZT) intolerance as evidenced by inability to tolerate at least 600 mg AZT daily.
- Previously intolerant to didanosine (ddI) evidenced by peripheral neuropathy or seizures or pancreatitis or gastrointestinal toxicity or hematologic toxicity.
- Diseases or conditions listed under Patient Exclusion Co-existing Conditions.
- Prior Medication:
- Excluded:
- Zidovudine (AZT) for > 120 days.
- Dideoxycytidine (ddC).
- Excluded within 30 days of study entry:
- Antiretroviral therapy.
- Immunomodulators.
- Biological response modifiers.
- Cytotoxic chemotherapy for Kaposi's sarcoma.
- Excluded within 60 days of study entry:
- Ribavirin.
- Prior Treatment:
- Excluded within 2 weeks of study entry:
- Transfusions.
- Excluded within 30 days of study entry:
- Radiation therapy for Kaposi's sarcoma.
- Active substance abuse that would impair compliance with study procedures.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New England Med Ctr
Boston, Massachusetts, 02111
Univ of Miami School of Medicine
Miami, Florida, 331361013
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 981224304
About this study
To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Didanosine
- Keywords
- Didanosine, Drug Evaluation, Zidovudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002014
- Sponsor's protocol ID
- 052A
- Other IDs
- 01
- Status last verified
- Aug 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lorenzen S, Quante M, Rauscher I, Slotta-Huspenina J, Weichert W, Feith M, Friess H, Combs SE, Weber WA, Haller B, Angele M, Albertsmeier M, Blankenstein C, Kasper S, Schmid RM, Bassermann F, Schwaiger M, Liffers ST, Siveke JT. PET-directed combined modality therapy for gastroesophageal junction cancer: Results of the multicentre prospective MEMORI trial of the German Cancer Consortium (DKTK). Eur J Cancer. 2022 Nov;175:99-106. doi: 10.1016/j.ejca.2022.07.027. Epub 2022 Sep 10.
PubMed 36099671
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 Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT00002014
- Acronym / sponsor ID
- 052A
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Evaluation, Zidovudine
- Phase
- Phase 1
- 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 determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.
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 (10 listed)
- Acyclovir not to exceed two 14-day courses of therapy during trial. Discontinue ddI while receiving acyclovir.
- Positive HIV antibody using federally licensed ELISA test kit.
- CD4 counts < 400 on two consecutive visits within one month prior to entry.
- Zidovudine (AZT) if treated for less than 120 days.
- Pharmacologic doses of steroids if given for management of Pneumocystis carinii pneumonia (PCP) (not to exceed 21 days).
Key exclusion criteria (37 listed)
- Visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the thirty days prior to entry) or patients who require chemotherapy or radiation therapy for Kaposi's sarcoma. Other concurrent neoplasms other than basal cell carcinoma of skin or in situ carcinoma of the cervix. Malabsorption as defined by persistent diarrhea ( > 4 stools/day for four weeks) which is unresponsive to antidiarrheal agents. Opportunistic infection requiring maintenance therapy. History of Central Nervous System opportunistic infections (e.g., toxoplasmosis, cryptococcosis). History of seizure disorders. Prior history of pancreatitis. History of peripheral neuropathy or any significant signs or symptoms of neurological disease. Examinations for peripheral neuropathy should assess changes in extremities. Clinically significant hyperuricemia (tophaceous gout, urate nephropathy). History of cardiomyopathy.
- Intravenous pentamidine.
- Intravenous trimethoprim / sulfamethoxazole.
- Alcohol.
- Suppressive acyclovir therapy (see Inclusion Medications).
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 | – |
| 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.
- Derived from this study: PubMed 36099671Lorenzen S, Quante M, Rauscher I, Slotta-Huspenina J, Weichert W, Feith M, Friess H, Combs SE, Weber WA, Haller B, Angele M, Albertsmeier M, Blankenstein C, Kasper S, Schmid RM, Bassermann F, Schwaiger M, Liffers ST, Siveke JT. PET-directed combined modality therapy for gastroesophageal junction cancer: Results of the multicentre prospective MEMORI trial of the German Cancer Consortium (DKTK). Eur J Cancer. 2022 Nov;175:99-106. doi: 10.1016/j.ejca.2022.07.027. Epub 2022 Sep 10.
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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.
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 Zidovudine and Didanosine in people with HIV Infections, run by Glaxo Wellcome 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 10 inclusion and 37 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 NCT00002014, 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.