A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and … (NCT00000656) | Clinical Trial Compass
CompletedPhase 1
A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
United States116 participants
Plain-language summary
To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness.
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:
* Aerosolized pentamidine.
* Acute and intermittent therapy with mycostatin and mycelex.
* Isoniazid, if no alternative therapy is available.
Allowed for up to 2 weeks:
* Acyclovir for Herpes infection (withhold didanosine during therapy).
* Acute therapy with fluconazole or ketoconazole.
Allowed but preferably not on a continuous basis for \> 72 hours:
* Acetaminophen.
* Ibuprofen.
* Nonsteroidal antiinflammatory agents.
Patients must be:
* HIV antibody positive.
* Asymptomatic or have persistent generalized lymphadenopathy.
* Diagnosed with one of the listed coagulopathies.
* OR Sexual partner of someone with the above criteria.
Allowed:
* Basal cell carcinoma or in situ carcinoma of the cervix.
NOTE:
* As of January, 1991 full accrual of patients with prior AZT use has been reached - NOW ACCRUING ONLY THOSE WITH NO PRIOR AZT USE. Hemophilia restriction has been lifted.
Prior Medication:
Allowed:
* Zidovudine (AZT) for a total of = or \< 13 months.
NOTE:
* As of January, 1991 accrual of these patients was reached, NOW ONLY PATIENTS WITH NO PRIOR AZT.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Unexplained temperature \> 38 degrees C for more than 5 consecutive days or on more than 10 days in any 30-day period in the 2 years prior to study entry.
* Unexplained diarrhea defined as at least 3 liquid stools/day persisting more than 7 days wit…
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 IDNCT00000656
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)