HIV InfectionsPhase 3NCT00000994
A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.
Trial summary
To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zidovudine
- How many people
- 240 participants
- Where
- 22 sitesUnited States
- Study dates
- Start not givento May 1990
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections.
- Concurrent Treatment:
- Allowed:
- Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
- Patients must have:
- HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions will be excluded:
- Symptomatic, visceral Kaposi's sarcoma.
- Lymphedema.
- HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire.
- Concurrent Medication:
Show all 38Show fewer
- Excluded:
- Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator.
- Cimetidine.
- Flurazepam.
- Indomethacin.
- Ranitidine.
- Probenecid.
- Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.
- Prophylaxis or chronic suppression of herpes simplex.
- Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days.
- Concurrent Treatment:
- Excluded:
- Radiation therapy for treatment of Kaposi's sarcoma lesions.
- The following patients will be excluded from the study:
- Patients with a history of any AIDS-defining opportunistic infection.
- Patients with any of the following constitutional symptoms with no etiology established:
- Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent.
- Patients with a history of other systemic malignancies or lymphomas.
- Prior Medication:
- Excluded:
- Systemic antineoplastic chemotherapy.
- Zidovudine (AZT).
- Excluded within 30 days of study entry:
- Antiretroviral agents.
- Immunomodulating agents.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Prophylaxis for herpes simplex virus infections.
- Any other experimental therapy.
- Prior Treatment:
- Excluded within 30 days of study entry:
- Any experimental therapy.
- Active substance abuse.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Duke Univ Med Ctr
Durham, North Carolina, 27710
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Minnesota
Minneapolis, Minnesota, 55455
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
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 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 Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468
About this study
Official title: A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma
To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Read the detailed description
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.
- Conditions
- HIV Infections
- Being tested
- Zidovudine
- Keywords
- AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Zidovudine
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, 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)
- Study completionMay 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Valentine FT, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000994
- Sponsor's protocol ID
- ACTG 001
- Other IDs
- 10977
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Chaisson RE, Fuchs E, Stanton DL, Quinn TC, Hendricksen C, Bartlett JG, Farzadegan H. Racial heterogeneity of HIV antigenemia in people with HIV infection. AIDS. 1991 Feb;5(2):177-80. doi: 10.1097/00002030-199102000-00007.
PubMed 1903261
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 Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00000994
- Acronym / sponsor ID
- ACTG 001
- Conditions
- HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Zidovudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 1990 (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 determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Detailed description
Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.
Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections.
- Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
- HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms.
Key exclusion criteria (38 listed)
- Symptomatic, visceral Kaposi's sarcoma.
- Lymphedema.
- HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire.
- Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator.
- Cimetidine.
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 1903261Chaisson RE, Fuchs E, Stanton DL, Quinn TC, Hendricksen C, Bartlett JG, Farzadegan H. Racial heterogeneity of HIV antigenemia in people with HIV infection. AIDS. 1991 Feb;5(2):177-80. doi: 10.1097/00002030-199102000-00007.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Valentine FT study chair
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 8 inclusion and 38 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00000994, which also lists 1 linked publication.
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.