ClinicalTrials.gg
CompletedNCT00002005Updated Jun 24, 2005

A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

An interventional study of CD4 Antigens in HIV Infections, sponsored by Genentech, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 67 studies in HIV Infections by Hoffmann-La Roche — none open to participants now, none under way, none of them phase 3. HIV Infections · Hoffmann-La Roche.

No phase
16 of 67
none open now
Registered
1st of 67
by date

Among the 67 studies in HIV Infections by Hoffmann-La Roche, this one is one of 16 with no phase, and was the 1st registered.

HIV Infections

4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.

Browse HIV Infections studies →

Open to participants now

None of the 67 studies in HIV Infections by Hoffmann-La Roche is open now. The open studies under HIV Infections, anywhere →

Who these studies take

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.

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02

Study summary

To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.

03

Conditions studied

  • HIV Infections

Keywords

  • Acquired Immunodeficiency Syndrome
  • Antigens, CD4
  • AIDS-Related Complex
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

Patients must have:

  • -1 seropositivity.
  • Diagnosis of AIDS or AIDS related complex (ARC).
  • Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
  • The ability to sign a written form prior to treatment.
  • A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
  • A of at least 3 months.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Serious active opportunistic infections.
  • other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).
  • .
  • Nonsteroidal anti-inflammatory agents (NSAI).
  • Other experimental therapy.

Patients with the following are excluded:

  • Serious active opportunistic infections.
  • Malignancies other than Kaposi's sarcoma.

Prior Medication:

Excluded within 3 weeks of study entry:

  • Zidovudine (AZT).
  • Chemotherapy.
  • Immunomodulators.
  • Other experimental therapy.
Terms in these criteria, in plain language(5)

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.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

06

Study locations

1 site
  • Genentech Inc
    South San Francisco, California 94080, United States
07

References and documents

Publications

  • Arranz R, Garcia-Noblejas A, Grande C, Cannata-Ortiz J, Sanchez JJ, Garcia-Marco JA, Alaez C, Perez-Calvo J, Martinez-Sanchez P, Sanchez-Gonzalez B, Canales MA, Conde E, Martin A, Arranz E, Terol MJ, Salar A, Caballero D. First-line treatment with rituximab-hyperCVAD alternating with rituximab-methotrexate-cytarabine and followed by consolidation with 90Y-ibritumomab-tiuxetan in patients with mantle cell lymphoma. Results of a multicenter, phase 2 pilot trial from the GELTAMO group. Haematologica. 2013 Oct;98(10):1563-70. doi: 10.3324/haematol.2013.088377. Epub 2013 Jun 10. PubMed 23753021 ↗
  • Picado A, Singh SP, Rijal S, Sundar S, Ostyn B, Chappuis F, Uranw S, Gidwani K, Khanal B, Rai M, Paudel IS, Das ML, Kumar R, Srivastava P, Dujardin JC, Vanlerberghe V, Andersen EW, Davies CR, Boelaert M. Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial. BMJ. 2010 Dec 29;341:c6760. doi: 10.1136/bmj.c6760. PubMed 21190965 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002005
Lead sponsor
Genentech, Inc.
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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Studies of the drug tested here: CD4 Antigens

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