HIV InfectionsPhase 1NCT00000999
The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC
A Phase 1 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 sites in United States.
Trial summary
To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity. 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
- 500 participants
- Where
- 23 sitesUnited States
- Study dates
- Start not givento Mar 1989
- 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:
- For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (> 72 hours) administration is not advised without dose supervision.
- Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories:
- AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol.
- Patients who qualify for AZT under the labeling:
Show all 10Show fewer
- (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and < 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or > 15 lbs or > 10 percent of total body weight within the previous 3 months) and < 200 T4 cells and one or more of the following symptoms:
- (1) fever > 100 degrees F without infectious cause of > 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare.
- Note:
- Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling.
Who cannot join
- Co-existing Condition:
- Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded.
- Concurrent Medication: Excluded:
- Acetaminophen.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Duke Univ Med Ctr
Durham, North Carolina, 27710
LaJolla Veterans Administration Med Ctr
La Jolla, California, 92037
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Minnesota
Minneapolis, Minnesota, 55455
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
Stanford Univ School of Medicine
Stanford, California, 94305
SUNY / State Univ of New York
Syracuse, New York, 13210
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465
About this study
Official title: A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS and Advanced ARC
To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity.
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
Read the detailed description
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.
- 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)
- Study completionMar 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Pettinelli C, Study chairFeinberg J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000999
- Sponsor's protocol ID
- ACTG 020
- Other IDs
- 10996
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Jacobson MA, Bacchetti P, Kolokathis A, Chaisson RE, Szabo S, Polsky B, Valainis GT, Mildvan D, Abrams D, Wilber J, et al. Surrogate markers for survival in patients with AIDS and AIDS related complex treated with zidovudine. BMJ. 1991 Jan 12;302(6768):73-8. doi: 10.1136/bmj.302.6768.73.
PubMed 1671651Jacobson MA, Abrams DI, Volberding PA, Bacchetti P, Wilber J, Chaisson RE, Crowe S, Howard W, Moss A. Serum beta 2-microglobulin decreases in patients with AIDS or ARC treated with azidothymidine. J Infect Dis. 1989 Jun;159(6):1029-36. doi: 10.1093/infdis/159.6.1029.
PubMed 2566637Jacobson MA, Abrams D, Bacchetti P, Kocurek K, Wilber J, Moss AR. Change in beta-2 microglobulin (B2M) during zidovudine (ZDV) therapy (RX) predicts clinical outcome. Int Conf AIDS. 1989 Jun 4-9;5:339 (abstract no TBP312)
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Uncontrolled Trial To Evaluate the Long Term Safety and Tolerance of Zidovudine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS and Advanced ARC
- ClinicalTrials.gov ID
- NCT00000999
- Acronym / sponsor ID
- ACTG 020
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1989 (actual)
- 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 obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity.
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
Detailed description
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (> 72 hours) administration is not advised without dose supervision.
- Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories:
- AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol.
- Patients who qualify for AZT under the labeling:
- (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and < 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or > 15 lbs or > 10 percent of total body weight within the previous 3 months) and < 200 T4 cells and one or more of the following symptoms:
Key exclusion criteria (4 listed)
- Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded.
- Acetaminophen.
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 4 Nov 2021.
- Background: PubMed 1671651Jacobson MA, Bacchetti P, Kolokathis A, Chaisson RE, Szabo S, Polsky B, Valainis GT, Mildvan D, Abrams D, Wilber J, et al. Surrogate markers for survival in patients with AIDS and AIDS related complex treated with zidovudine. BMJ. 1991 Jan 12;302(6768):73-8. doi: 10.1136/bmj.302.6768.73.
- Background: PubMed 2566637Jacobson MA, Abrams DI, Volberding PA, Bacchetti P, Wilber J, Chaisson RE, Crowe S, Howard W, Moss A. Serum beta 2-microglobulin decreases in patients with AIDS or ARC treated with azidothymidine. J Infect Dis. 1989 Jun;159(6):1029-36. doi: 10.1093/infdis/159.6.1029.
- BackgroundJacobson MA, Abrams D, Bacchetti P, Kocurek K, Wilber J, Moss AR. Change in beta-2 microglobulin (B2M) during zidovudine (ZDV) therapy (RX) predicts clinical outcome. Int Conf AIDS. 1989 Jun 4-9;5:339 (abstract no TBP312)
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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.
Pettinelli C study chair
Feinberg J study chair
23 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 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 23 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 4 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 NCT00000999, which also lists 3 linked publications.
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 4 Nov 2021.