HIV InfectionsNCT00002063
Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 8 sites in United States.
Trial summary
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. 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
- 8 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
Who cannot join
- Co-existing Condition:
- Patients with unstable disease characterized by the following are excluded:
- Hospitalization within the past 14 days.
- Major opportunistic infection, current or past.
- An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as:
- Temperature = or > 100.5 degrees F.
Show all 31Show fewer
- Night sweats.
- Weight loss = or > 10 percent of body weight.
- Diarrhea (3 or more bowel movements/day).
- Persistent cough, shortness of breath, or dyspnea on exercise.
- Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a) gradient.
- Altered mental status, seizures, or focal neurologic signs.
- Abnormal computerized tomography (CT) scan or magnetic resonance imaging (MRI) suggestive of toxoplasmosis, peripheral mononuclear leukocytes, lymphoma, or other focal abnormality of the central nervous system (CNS).
- Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or other meningitis. (The decision to perform invasive tests, such as lumbar puncture, specialized microbiological tests such as bone marrow culture for Mycobacteria or Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI should be based on clinical assessment of the patient.)
- Kaposi's sarcoma.
- Lymphoma; malignancy requiring chemotherapy.
- Dementia.
- Requiring hemodialysis or renal insufficiency or failure.
- Leukopenia.
- Thrombocytopenia.
- Patients with the following are excluded:
- Unstable disease.
- Kaposi's sarcoma.
- Lymphoma; malignancy requiring chemotherapy.
- Dementia.
- Major opportunistic infection, current or past.
- Anemia (hemoglobin less than 9.5 g/dl).
- Prior Medication:
- Excluded within 1 month of study entry:
- Ribavirin or zidovudine (AZT) or other antivirals.
- Immunomodulating agents.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Veterans Affairs Med Ctr / Admin Only / Not For Patient Care
Durham, North Carolina, 27705
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Wadsworth Veterans Administration Med Ctr
Los Angeles, California, 90073
Dr Gordon Dickinson
Miami, Florida, 33136
Dr Gigi Diamond / New York Veterans Administration
New York, New York, 10010
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 203075001
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
About this study
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Immune Tolerance, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, AIDS-Related Complex
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
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002063
- Sponsor's protocol ID
- 016A
- Other IDs
- VA Study 298
- Status last verified
- Jan 1990
- 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
- Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
- ClinicalTrials.gov ID
- NCT00002063
- Acronym / sponsor ID
- 016A
- Conditions
- HIV Infections
- Keywords
- Immune Tolerance, AIDS-Related Complex, 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.
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.
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 (1 listed)
- Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
Key exclusion criteria (31 listed)
- Hospitalization within the past 14 days.
- Major opportunistic infection, current or past.
- An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as:
- Temperature = or > 100.5 degrees F.
- Night sweats.
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.
8 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 HIV Infections, run by Glaxo Wellcome at 8 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 1 inclusion and 31 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 8 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.