Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV (NCT01125228) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV
United States180 participantsStarted 1988-10-19
Plain-language summary
This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-infected patients.
HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more and no current opportunistic infections may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, chest X-ray, electrocardiogram, urinalysis, and, for patients with Kaposi s sarcoma lesions, measurement, photographs, and biopsy of lesions.
Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus interferon or interferon alone. They will continue treatment until one of the following occurs:
* Unacceptable side effects, despite dose modifications
* Development of an opportunistic infection
* Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3
* Rapid progression of Kaposi s sarcoma lesions, requiring alternative therapy
* A decision is made to terminate the study
Patients will be followed long term for viral load, immune function, development of opportunistic infections, disease progression, and survival.
...
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:
Over 18 years of age.
T4 lymphocyte count greater than or equal to 500/mm3.
Infection with HIV as documented by positive ELISA and Western blot and positive HIV culture or positive p24 antigen or positive polymerase chain reaction.
Absence of current opportunistic infection (defined for purposes of this study as: candidiasis, cryptosporidiosis, mycobacterial infection, persistent herpes simplex infection, isosporiasis, cytomegalovirus infection, toxoplasmosis, pneumocystosis, salmonellosis, and cryptococcosis). Routine clinical methods and observations were performed to exclude such patients.
Afebrile (Temperature less the 38 degrees Centigrade orally) without antipyretics for at least 72 hours prior to enrollment.
Performance status 0, 1, or 2.
Relatively stable clinical condition, with no deterioration of performance status in the month prior to enrollment.
Ability to give informed consent and willing to comply with all procedures and visits scheduled.
Suitability of I.V. access for the scheduled blood tests.
Normal renal function as defined by BUN less than or equal to 30 and creatinine less than or equal to 1.5.
Normal hepatic function with transaminases and alkaline phosphatase less than 5 times the upper limit of normal range.
Hemoglobin greater than or equal to 10 gm/dl, total granulocyte count greater than or equal to 1250/mm(3), platelet count greater than or equal to 125,000/mm(3).
No previous therapy for KS within the month prior …
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.
1This trial is comparing zidovudine alone, zidovudine plus alpha interferon, and interferon alone for HIV — given my current health status and any treatments I'm already on, which of these three approaches, if any, might be relevant to my situation?
2Since this study is listed as 'active not recruiting,' it's no longer enrolling new patients — does that mean I can't participate, and are there newer or similar trials still open that might be worth exploring instead?
3The trial's primary focus seems to be long-term follow-up and sample collection rather than testing a new treatment — what does that mean in practical terms for what I'd actually be doing if I were somehow involved, and how does that differ from a trial offering an active new therapy?
4Zidovudine has been around for decades as an HIV treatment — can you help me understand how this older drug combination compares to what's currently considered the standard of care for HIV, so I know whether a trial like this is even relevant to my treatment options today?
5Since this trial doesn't have a standard phase listed, what does that tell us about how much is already known about the safety and effectiveness of these drug combinations, and should that affect how I think about trials like this one?
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.
What they're measuring
1
Long term follow up
Timeframe: ongoing
2
sample collection
Timeframe: ongoing
Trial details
NCT IDNCT01125228
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)