CompletedPhase 3

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

United States482 participants

Plain-language summary

To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00000700

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

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