A Phase 1 interventional study of Zidovudine and Zalcitabine in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-08.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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Among 193 studies testing zidovudine in HIV Infections — none open to participants now, 1 under way, none of them phase 3. Zidovudine · HIV Infections.
Among the 193 studies testing zidovudine in HIV Infections, this one is the 96th largest by enrollment of the 162 interventional ones that give a count, is one of 42 in phase 1, and was the 1st registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →None of the 193 studies testing zidovudine in HIV Infections is open now. The open studies under HIV Infections, anywhere →
Zidovudine: first FDA approval 1987 (RETROVIR), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · 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.
193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 49 · Phase 3 42 · Phase 4 7
First in 1991; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is below the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 105 across the 162 interventional studies. Of the 188 that completed or were terminated, 10 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 193 have an industry lead sponsor. The 10 most frequent:
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 406 completed or terminated interventional studies of FDA-regulated products, 302 (74%) have results posted.
1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID): 10 open now, 15 under way, 1 of them phase 3. Of 962 finished, 130 (14%) have results posted.
Among the 1,034 studies in HIV Infections by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 404th largest by enrollment of the 883 interventional ones that give a count, is one of 365 in phase 1, and was the 1st registered.
National Institute of Allergy and Infectious Diseases (NIAID)’s HIV Infections studies by the year they started, since 1984.
None of the studies under way reaches primary completion within a year.
Among the 193 studies testing zidovudine in HIV Infections, from their registry updates:
Among National Institute of Allergy and Infectious Diseases (NIAID)’s 1,034 in HIV Infections:
This tab as a report to print or save as PDF → With an account.
To determine the safety, tolerability, and activity of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) and the bloodstream levels of these drugs in patients with AIDS or advanced AIDS-related complex (ARC).
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Treatments using AZT alternating with ddC are being evaluated in ongoing trials with a goal of reducing the toxicity of each while maintaining antiviral effects. In addition, AZT and ddC may work together in a way that both drugs can be taken at lower doses or less frequent intervals when given together. If the doses can be reduced, then toxicity associated with long-term use of one drug may be reduced. Combination of AZT and ddC might reduce the likelihood of the emergence of resistant mutants. Recent studies indicate a reduced sensitivity of HIV isolated from patients after prolonged AZT therapy. Although the clinical significance of this finding is not clear, it would indicate that these combination studies are all the more important. HIV strains with decreased sensitivity to AZT are still sensitive to ddC.
Patients are randomly assigned to one of six treatment groups of various dose combinations of AZT and ddC. Patients are evaluated every week for the first 10 weeks and biweekly thereafter.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients are excluded if unwilling or unable to sign .
Prior Medication:
Excluded:
Positive antibody to using any federally licensed ELISA test kit. Diagnosis of AIDS or AIDS-related complex (ARC).
Active substance or alcohol abuse.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
This study is completed, as verified in Aug 1992. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zidovudine
National Institute of Allergy and Infectious Diseases (NIAID) →