HIV InfectionsNCT00002046
A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
A study testing Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 11 sites in United States.
Trial summary
To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine
- How many people
- Not given
- Where
- 11 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
- Concurrent Treatment:
- Allowed:
- Electron beam therapy to an area of less than 100 cm2.
- Patients with the following are excluded:
- Any immediately life-threatening infection or medical condition present at the time of study entry.
- Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.
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- Patients with Pneumocystis carinii pneumonia (PCP) may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 degrees C for at least 48 hours; oxygen (on room air)
- = or > 60 mm, and arterial / alveolar gradient = or < 30 mm.
- Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
- Seropositive for HIV antibody documented by any federally licensed ELISA.
- Patients must have ability to give informed consent and advanced HIV disease defined as:
- History of Pneumocystis carinii pneumonia (PCP) with histologic verification within 4 months of study entry.
- OR History of other opportunistic infection included in the CDC surveillance definition of AIDS (stage IV-C-1), diagnosed within 4 months of entry, but not requiring chronic suppressive therapy, and a CD4+ cell count < 200 cells/mm3.
- OR AIDS related complex (ARC) only those patients with a CD4+ count < 200 cells/mm3 and documentation of at least two signs or symptoms from the list below. One sign or symptom must be weight loss or candidiasis as described.
- Unexplained weight loss > 10 percent or = or > 15 lbs within the previous 4 months; with low weight at entry.
- History of mucocutaneous oral candidiasis (by culture or potassium hydroxide KOH smear).
- Fever > 38 degrees C, without documented infectious cause present, persisting > 1 month.
- Oral hairy leukoplakia.
- Unexplained night sweats, persisting > 1 month.
- Herpes zoster infection within 3 months of entry.
- Chronic diarrhea of unknown infectious etiology persisting > 1 month after 3 samples have been done eliminating ova, parasites, Cryptosporidia, Mycobacterium avium intracellulare, cytomegalovirus (CMV), and other pathogens associated with diarrheal disease in AIDS patients.
- Negative Venereal Disease Research Laboratory (VDRL) or Rapid Plasma Reagent (RPR) or, if positive and verified by Fluorescent Treponemal Antibody Absorption (FTAABS), documented history of treatment for syphilis. If FTAABS is positive, but treatment history is not available, the patient may be entered 3 or more days following the initiation of appropriate chemotherapy.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Chronic herpes virus infection.
- Fever > 39 degrees C at study entry.
- Known hypersensitivity to lactate and/or gelatin.
- Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
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- Impaired renal function.
- AIDS dementia complex.
- Concurrent Medication:
- Excluded:
- Drugs which cause significant bone marrow suppression.
- Rifampin or rifampin derivatives.
- Drugs which cause significant nephrotoxicity or hepatotoxicity.
- Antiretroviral agents, including ribavirin, dideoxycytidine, dideoxyadenosine, didanosine, foscarnet, dextran sulfate, and AL-721.
- Acyclovir therapy of more than 21 days duration.
- Concurrent Treatment:
- Excluded:
- Radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
- Experimental therapy.
- Cytolytic chemotherapy.
- Prior Medication:
- Excluded:
- Acyclovir therapy of more than 21 days duration.
- Zidovudine (AZT).
- Excluded within 2 weeks of study entry:
- Drugs which cause significant bone marrow suppression.
- Rifampin or rifampin derivatives.
- Drugs which cause significant nephrotoxicity or hepatotoxicity.
- Immunomodulating agents, including pharmacologic doses of steroids for > 10 days.
- Excluded within 4 weeks of study entry:
- Interferon.
- Isoprinosine.
- IL-2.
- Excluded within 8 weeks of study entry:
- Antiretroviral agents, including ribavirin, dideoxycytidine, dideoxyadenosine, didanosine, foscarnet, dextran sulfate, and AL-721.
- Prior Treatment:
- Excluded:
- Radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).
- Experimental therapy.
- Cytolytic chemotherapy.
- Active drug or alcohol abuse.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Baylor College of Medicine
Houston, Texas, 77030
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
About this study
To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to these patients.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, 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
- NCT00002046
- Sponsor's protocol ID
- 014G
- Other IDs
- 18
- Status last verified
- May 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
- A Dose-Frequency Trial of Oral Retrovir in Patients With AIDS or Severe ARC
- ClinicalTrials.gov ID
- NCT00002046
- Acronym / sponsor ID
- 014G
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, 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.
To evaluate the pharmacokinetics of Retrovir (AZT) administered orally as 1 of 3 doses in the treatment of patients with severe clinical and laboratory manifestations of HIV infection. To compare the safety and tolerance of AZT administered 2, 3, and 6 x daily to 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 (22 listed)
- Electron beam therapy to an area of less than 100 cm2.
- Any immediately life-threatening infection or medical condition present at the time of study entry.
- Any active opportunistic or other infection requiring chronic therapy present at the time of study entry.
- Patients with Pneumocystis carinii pneumonia (PCP) may be randomized to study medication following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 degrees C for at least 48 hours; oxygen (on room air)
- = or > 60 mm, and arterial / alveolar gradient = or < 30 mm.
Key exclusion criteria (41 listed)
- Chronic herpes virus infection.
- Fever > 39 degrees C at study entry.
- Known hypersensitivity to lactate and/or gelatin.
- Kaposi's sarcoma, lymphoma, or other tumor likely to require cytotoxic chemotherapy.
- Impaired renal function.
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.
11 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 11 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 22 inclusion and 41 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 11 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.