Lymphatic DiseaseNCT00002048
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
A study testing Zidovudine in people with Lymphatic Disease and HIV Infections, run by Glaxo Wellcome at 22 sites in United States.
Trial summary
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Lymphatic Disease, HIV Infections
- What is being tested?
- Zidovudine
- How many people
- Not given
- Where
- 22 sitesUnited 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which would impair study completion.
- Liver dysfunction as demonstrated by lab results.
- Laboratory evidence of compromised bone marrow function.
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- Concurrent Medication:
- Excluded:
- Any other experimental agents.
- Any probenecid-containing product.
- Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
- Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
- Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
- Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period.
- OR History of secondary infections associated with AIDS related complex (ARC) including:
- Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
- Herpes zoster infection within 3 years.
- Oral hairy leukoplakia at any time.
- OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
- Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
- Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
- Prior Medication:
- Excluded:
- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
- Excluded within 4 weeks of study entry:
- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
- Excluded within 3 months of study entry:
- Antiretroviral drugs or biologic response modifiers.
- Excluded within 4 months of study entry:
- Systemic corticosteroids.
- Patients must meet the following criteria:
- HIV infection demonstrated by ELISA and confirmed by Western blot.
- Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
- Ability to give informed consent.
- Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Med Univ of South Carolina
Charleston, South Carolina, 29425
Nalle Clinic
Charlotte, North Carolina, 28207
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Baylor College of Medicine
Houston, Texas, 77030
LaJolla Veterans Administration Med Ctr
La Jolla, California, 92037
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
Univ of Miami School of Medicine
Miami, Florida, 331361013
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Graduate Hosp
Philadelphia, Pennsylvania, 19146
Oregon Health Sciences Univ
Portland, Oregon, 97201
Good Samaritan Hosp
Portland, Oregon, 972103079
Med College of Virginia
Richmond, Virginia, 23298
Dr Kristen Reis
Salt Lake City, Utah, 84132
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
AIDS Clinical Trials Group
San Diego, California, 92103
Univ of South Florida
Tampa, Florida, 33612
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103
About this study
To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
- Conditions
- Lymphatic Disease, HIV Infections
- Being tested
- Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- Lymphatic Diseases, 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
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 Lymphatic DiseaseStudies 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
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002048
- Sponsor's protocol ID
- 014J
- Other IDs
- 21
- Status last verified
- Sep 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
- The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
- ClinicalTrials.gov ID
- NCT00002048
- Acronym / sponsor ID
- 014J
- Conditions
- Lymphatic Disease, HIV Infections
- Keywords
- 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 safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (36 listed)
- Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which would impair study completion.
- Liver dysfunction as demonstrated by lab results.
- Laboratory evidence of compromised bone marrow function.
- Any other experimental agents.
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.
22 sites 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 Lymphatic Disease and HIV Infections, run by Glaxo Wellcome at 22 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 0 inclusion and 36 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 22 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.
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.