HIV InfectionsNCT00002045
A Prospective Double-Blind Study of Retrovir in Early HIV Infection
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients. (12/01/89) Information supplied by drug company update. 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
- How many people
- Not given
- Where
- 1 siteUnited States
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Treatment:
- Allowed:
- Electron beam therapy to an area of less than 100 cm2.
- Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).
- Patient must be able to give informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
- Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
- Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
- extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
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- Evidence of compromised bone marrow function defined by specified lab values.
- Evidence of HIV neurologic disease.
- Evidence of HIV-associated "wasting syndrome".
- Hypersensitivity to zidovudine (AZT).
- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents.
- Steroids.
- Interferon or immunomodulating agents.
- Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.
- Patients with the following are excluded:
- Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
- extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
- Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
- Evidence of HIV-associated wasting syndrome.
- Hypersensitivity to retrovir.
- Prior Medication:
- Excluded within 4 weeks of study entry:
- Interferon.
- Immunomodulating agents.
- Myelosuppressive drugs.
- Nephrotoxic agents.
- Other experimental chemotherapy.
- Prior Treatment:
- Excluded:
- Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
- Chronic alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
About this study
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Prospective Studies, 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
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 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
- NCT00002045
- Sponsor's protocol ID
- 014E
- Other IDs
- 15
- Status last verified
- Dec 1989
- 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 Prospective Double-Blind Study of Retrovir in Early HIV Infection
- ClinicalTrials.gov ID
- NCT00002045
- Acronym / sponsor ID
- 014E
- Conditions
- HIV Infections
- Keywords
- Prospective Studies, 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 safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
(12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.
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 (5 listed)
- Electron beam therapy to an area of less than 100 cm2.
- Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).
- Patient must be able to give informed consent.
Key exclusion criteria (33 listed)
- Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
- Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
- Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
- extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
- Evidence of compromised bone marrow function defined by specified lab values.
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 | – |
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 1 site 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 5 inclusion and 33 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 1 site 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.
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.