Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals (NCT00000736) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
United States3,200 participants
Plain-language summary
To determine if treatment with zidovudine (AZT) will delay or prevent the onset of AIDS or AIDS related complex (ARC) in individuals infected with HIV but who do not have symptoms of AIDS or ARC. Also, to compare the dose of AZT found to be useful in AIDS and severe ARC with a lower dose to see if side effects can be reduced.
Results from several studies show that a high percentage of people infected with HIV will eventually develop AIDS or ARC unless an effective treatment is found. Because AZT is known to prolong survival in patients with AIDS or severe ARC and has acceptable toxicity in advanced disease, it is reasonable to try it in less advanced cases.
Who can participate
Age range
18 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
Patients must:
* Be HIV seropositive and asymptomatic.
* Have normal neurologic exam as defined by the Micro Neuro-AIDS assessment.
Concurrent Medication
* Required: Prophylaxis for Pneumocystis carinii pneumonia (PCP). Aerosolized pentamidine is preferred but if not possible, Trimethoprim / sulfamethoxazole 1 DS tablet per day or Dapsone 50 - 100 mg per day is allowed.
Exclusion Criteria
* Active drug or alcohol abuse sufficient to prevent adequate compliance with study therapy in the investigator's opinion.
Co-existing Condition:
Patients with the following diseases or conditions are excluded:
* Hemophilia.
* Oral candida infection documented by morphology or by response to antifungal therapy within 2 years of study entry.
* Oral hairy leukoplakia at any time prior to study entry.
* Herpes zoster infection (including single dermatome infection) within 2 years of study entry.
* Active diarrhea as defined by 3 or more liquid stools per day.
* Temperature \> 37.8 degrees C.
* Grade 1 impairment on two or more items (mild AIDS dementia complex) in the ACTG Micro Neuro-AIDS Assessment.
* Prior history of malignancy other than cutaneous basal cell carcinomas or cervical carcinoma in situ.
Patients with the following are excluded from entry:
* AIDS or AIDS-related complex defining symptoms.
* Significant, chronic underlying medical illnesses which would impair continuous participation in this 3-year clinical trial.
* Hemophilia.
Prior Medication: Exc…
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 IDNCT00000736
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)