An interventional study of Zidovudine in HIV Infections, sponsored by Glaxo Wellcome. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Glaxo Wellcome (part of GlaxoSmithKline) · Not applicable, Interventional, and Treatment
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Among 68 studies testing zidovudine in AIDS-Related Complex — none open to participants now, none under way, none of them phase 3. Zidovudine · AIDS-Related Complex.
Among the 68 studies testing zidovudine in AIDS-Related Complex, this one is one of 19 with no phase, and was the 1st 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 68 studies testing zidovudine in AIDS-Related Complex is open now. The open studies under AIDS-Related Complex, 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 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: 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.
68 studies; the count open now beside each. This study's row is marked.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 180 across the 53 interventional studies. Of the 68 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 68 have an industry lead sponsor. The 10 most frequent:
This study is registered under Glaxo Wellcome, one of the names counted as GlaxoSmithKline. Under that name alone:
Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.
21 studies in AIDS-Related Complex by GlaxoSmithKline: none open now, none under way, none of them phase 3. Of 21 finished, 0 (0%) have results posted.
Among the 21 studies in AIDS-Related Complex by GlaxoSmithKline, this one is one of 13 with no phase, and was the 1st registered.
None of the studies under way reaches primary completion within a year.
Among the 68 studies testing zidovudine in AIDS-Related Complex, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 21 in AIDS-Related Complex:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.
283 studies on the registry are indexed under AIDS-Related Complex; 2 are open to participants now.
Browse AIDS-Related Complex studies →Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.
First submitted before Glaxo Wellcome became part of GlaxoSmithKline.
Compared within AIDS-Related Complex, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give .
Exclusion Criteria
Co-existing Condition:
Patients with unstable disease characterized by the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 1 month of study entry:
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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).
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
This study is completed, as verified in Jan 1990. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zidovudine