A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 C… (NCT00002155) | Clinical Trial Compass
CompletedNot Applicable
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC
United States600 participants
Plain-language summary
To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.
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
Concurrent Medication:
Allowed for all patients:
* Standard prophylaxis for opportunistic infections.
* Continuation of treatment for opportunistic infection.
Allowed for open-label study patients:
* Rifampin.
Patients must have:
* HIV positivity.
* CD4 count \<= 50 cells/mm3.
* More than 6 months of prior AZT (blinded study only).
NOTE:
* Patients on the open-label study must have AZT intolerance or have \< 6 months of prior AZT.
Prior Medication:
Required for blinded study patients:
* \> 6 months of prior AZT.
Required for open-label study patients:
* \< 6 months of prior AZT.
Allowed for open-label study patients:
* Prior 3TC.
Exclusion Criteria
Concurrent Medication:
Excluded in all patients:
* Immunosuppressants.
Excluded in blinded study patients:
* AZT, ddI, ddC, or d4T.
* Rifampin.
Excluded in open-label study patients:
* 3TC.
Prior Medication:
Excluded in all patients:
* Prior protease inhibitors.
* Investigational agents and immunomodulators within 30 days prior to study entry.
* Immunosuppressants within 2 weeks prior to study entry.
Excluded in blinded study patients:
* Any prior 3TC.
* AZT, ddI, ddC, or d4T within 2 weeks prior to study entry.
Excluded in open-label study patients:
3TC within 30 days prior to study 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.