A Phase 3 interventional study of zidovudine and 2',3'-dideoxyinosine in AIDS-Related Complex and Acquired Immunodeficiency Syndrome, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment
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Among 17 studies testing didanosine in AIDS-Related Complex — none open to participants now, none under way, none of them phase 3. Didanosine · AIDS-Related Complex.
Among the 17 studies testing didanosine in AIDS-Related Complex, this one is the 8th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 1990, is one of 3 in phase 3, and was the 17th registered.
283 studies on the registry are indexed under AIDS-Related Complex; 2 are open to participants now.
Browse AIDS-Related Complex studies →None of the 17 studies testing didanosine in AIDS-Related Complex is open now. The open studies under AIDS-Related Complex, anywhere →
Didanosine: first FDA approval 1991 (VIDEX). What it is approved for, and how studies give it, is on its page →
Of the 2 AIDS-Related Complex studies recruiting now, 1 sets no upper age limit and none stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 1 started in 1990.
This study's enrollment of 42 is below the median of 60 across 194 interventional studies indexed under AIDS-Related Complex.
Median enrollment 46 across the 14 interventional studies. Of the 16 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 17 have an industry lead sponsor. The 5 most frequent:
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
National Cancer Institute (NCI) has 1 study filed under AIDS-Related Complex — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing didanosine in AIDS-Related Complex, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.
Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.
Patients with AIDS or symptomatic infection who have 10-350 CD4+ T cells per mm(3) and an estimated life-expectancy of over 3 months.
For the purpose of this study, a patient is defined as having symptomatic HIV infection if he or she has a history of or has active thrush (oral candidiasis); a history of or active oral hairy leukoplakia; herpes zoster within the last 3 years; recurrent seborrheic dermatitis or puritic folliculitis; weight loss of 4.5 kg or 10 percent of body weight not caused by dieting; unexplained intermittent diarrhea (2 or more liquid stools per day) within the last 4 months; night sweats; mild cognitive impairment; or fatigue interfering with activity within the past 6 months.
Lymphadenopathy will not, in itself, be considered as sufficient for being considered as having symptomatic HIV infection.
All patients must have serum antibodies to HIV, ambulatory status, and capacity to give .
No prior use of dideoxynucleoside therapy (including but not restricted to AZT, ddC, or ddI) for over 3 months. However, preference will be given to patients who have received them for 1 month or less.
No pregnancy or the possibility of becoming pregnant during drug administration. Female patients of child-bearing age must have a negative pregnancy test just prior to enrollment and agree to practice while on the protocol.
No past or present evidence of renal disease (CRC1 estimated or determined to be less than 50 ml/min/1.73 m2).
Patients will be excluded if they have any one of the following hematologic abnormalities:
less than 10.0 gm per dl or transfusion within the last month, or
WBC less than 2000 per mm(3) or
less than 75,000 per mm(3).
No history of hepatic cirrhosis or present hepatic dysfunction with:
Total greater than 3.0 mg per dl (2x the ).
Alkaline phosphatase greater than 372 U per l (3x the upper limit of normal).
/GOT greater than 132 U per l (3x the upper limit of normal).
No evidence of severe diarrhea (over 5 stools per day), an underlying severe infection (including CMV retinitis, colitis, or pneumonitis); or evidence of Kaposi's sarcoma or other tumor which is likely to require specific anti-tumor therapy within 24 months of entering the study:
As a practical matter, only patients with Kaposi's sarcoma who have a few cutaneous lesions with no mucosal or internal lesions will be eligible.
Patients will be ineligible if they have some evidence of active life-threatening infections with bacterial, viral, fungal, or protozoan pathogens at the time of entry into the study. In general, patients who have had a fever of 39 degrees Celsius within the past 10 days will in general be ineligible unless it is apparent that this is not the result of a severe underlying infection.
No known reactions to or major toxicities from AZT or ddI. (This would include anaphylaxis reactions, hives, or Stevens Johnson syndrome, but would not include the minor rash occasionally seen with ddI.)
Patients must be willing to give informed consent, attend the outpatient clinic, and refrain from unprotected sexual contact or other activities which may result in re-infection with HIV. Present use of illicit drugs (for example, heroin or cocaine) or ingestion of substantial alcohol (enough to increase the risk of pancreatitis) will exclude the patient from the study.
No evidence of underlying cardiac disease, history of pancreatitis, or peripheral neuropathy.
No treatment within the last 4 months with suramin, treatment within the last 3 months with ribavirin, or treatment within the past 4 weeks with any anti-retroviral drug, cytotoxic chemotherapeutic agents, , interferon, or immunomodulating agents.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Oct 1990 and a completion of Apr 2000. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 1999. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Didanosine
National Cancer Institute (NCI) →