A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients (NCT00002354) | Clinical Trial Compass
CompletedNot Applicable
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
United States540 participants
Plain-language summary
The purpose of this study is to see if it is safe and effective to give indinavir sulfate plus stavudine to HIV-infected patients who have already been treated with zidovudine.
Who can participate
Age range
18 Years – 60 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:
* Prophylaxis with aerosolized pentamidine, topical antifungals, TMP / SMX, dapsone, or isoniazid.
Patients must have:
* HIV infection.
* CD4 count 50 - 500 cells/mm3.
* Prior AZT use for more than 6 months OR documented intolerance to AZT with more than 6 months use of another anti-HIV therapy other than d4T or any protease inhibitor.
* No active opportunistic infection or visceral Kaposi's sarcoma.
NOTE:
* Patients with hemophilia may be enrolled at discretion of investigator.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Symptomatic neuropathy.
* Acute hepatitis.
Concurrent Medication:
Excluded:
* Antiretrovirals other than specified in protocol.
* Chronic therapy for an active opportunistic infection.
* Immunosuppressive therapy.
Prior Medication:
Excluded:
* Any prior protease inhibitor or d4T.
* Any nucleoside analogs within 2 weeks prior to study entry.
* Investigational agents or immunomodulators within 30 days prior to study entry.
Required:
* More than 6 months of prior AZT unless intolerant, in which case more than 6 months of another anti-HIV therapy (other than protease inhibitors or d4T).
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.