A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000700 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: February 17, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Zidovudine | Phase 3 |
Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 482 participants |
Intervention Model: | Parallel Assignment |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP |
Actual Study Completion Date : | May 1990 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- All concomitant medication to minimum and record.
- Any approved medications can be used to treat an opportunistic infection.
- Dapsone may be used for Pneumocystis carinii pneumonia (PCP).
- Pyrimethamine - sulfadoxine may be used for toxoplasmosis.
- Ganciclovir for cytomegalovirus may be used for maintenance only.
- Prophylactic therapy for PCP.
Concurrent Treatment:
Allowed:
- Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used.
Patients must have:
- HIV seropositivity as confirmed by any federally licensed ELISA test kit.
- Allowed:
- Malignancy in past which has been in complete remission for 1 year without therapy.
Exclusion Criteria
Co-existing Condition:
Patients with active opportunistic infections will be excluded.
Concurrent Medication:
Excluded:
- Aspirin on a regular basis or beyond 72 hours without contacting investigator.
- Cimetidine.
- Flurazepam.
- Indomethacin.
- Ranitidine.
- Probenecid.
Patients with the following are excluded:
- Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry.
- Other concurrent neoplasms other than basal cell carcinoma of the skin.
- Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry.
- Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary.
Prior Medication:
Excluded within 2 weeks of study entry:
- Treatment for acute Pneumocystis carinii pneumonia (PCP).
- Excluded within 30 days of study entry:
- Other antiretroviral agents, immunomodulating agents, or corticosteroids.
Prior Treatment:
Excluded within 30 days of study entry:
- Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma.
Required:
- Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000700
United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Montefiore Med Ctr / Bronx Municipal Hosp | |
Bronx, New York, United States, 10467 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
Elmhurst, New York, United States, 11373 | |
Beth Israel Med Ctr / Peter Krueger Clinic | |
New York, New York, United States, 10003 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Univ of Pittsburgh Med School | |
Pittsburgh, Pennsylvania, United States | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98105 |
Study Chair: | Fischl M |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000700 History of Changes |
Other Study ID Numbers: |
ACTG 002 10978 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | February 17, 2012 |
Last Verified: | February 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
United States AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome Zidovudine |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases |
Slow Virus Diseases Zidovudine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |