The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Us… (NCT00000848) | Clinical Trial Compass
CompletedPhase 2
The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
United States144 participants
Plain-language summary
To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.
Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
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:
Required:
* PCP prophylaxis if CD4 count \<= 200 cells/mm3.
Allowed:
* Intralesional therapy for KS.
* Vitamins.
* Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study.
Concurrent Treatment:
Allowed:
* Acupuncture.
* Visualization techniques.
Patients must have:
* HIV infection.
* Prior hard capsule saquinavir at 1800 mg/day for more than 1 year.
Prior Medication:
Allowed:
* Prior saquinavir.
* Prior antiretrovirals, excluding protease inhibitors other than saquinavir.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Psychological condition or medical instability that would interfere with study evaluation or procedures.
AS PER AMENDMENT 5/7/97:
* Active tuberculosis.
Concurrent Medication:
Excluded:
* Protease inhibitors other than study drugs.
* Non-nucleoside RT inhibitors.
* Interferon.
* Interleukins.
* GM-CSF.
* HIV vaccines.
* Systemic cytotoxic chemotherapy.
* Investigational drugs other than study medications.
* Rifabutin.
* Rifampin.
* Midazolam.
* Triazolam.
* Ketoconazole.
* Delavirdine.
* Cisapride.
* Terfenadine.
* Astemizole.
AS PER AMENDMENT 5/7/97:
* Nevirapine.
Patients with the following prior conditions are excluded:
* Unexplained fever \> 38.5 C for any 7 days within 30 days prior to study entry.
* Diarrhea persisting for 15 days within 30 days prior to study entry.
Prior Medication:
Excluded:
* …
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 IDNCT00000848
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)