A Prospective Double-Blind Study of Retrovir in Early HIV Infection

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002045
15
014E

Details and patient eligibility

About

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) to adult patients with early manifestations of HIV disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients. (12/01/89) Information supplied by drug company update. Study discontinued due to positive data from ACTG 016.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

  • Electron beam therapy to an area of less than 100 cm2.

Patient must have signs and symptoms of HIV infection confined to those of stages WRII-V or CDC groups III IV-A, IV-C-2 (except recurrent Salmonella bacteremia, nocardiosis, or disseminated/extrapulmonary Mycobacterium tuberculosis), and IV-E (except diffuse interstitial lymphoid pneumonitis).

  • Patient must be able to give informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse.
  • Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria.
  • Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
  • extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
  • Evidence of compromised bone marrow function defined by specified lab values.
  • Evidence of HIV neurologic disease.
  • Evidence of HIV-associated "wasting syndrome".
  • Hypersensitivity to zidovudine (AZT).

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapeutic agents.
  • Steroids.
  • Interferon or immunomodulating agents.
  • Any antiretroviral drug including, but not limited to zidovudine (AZT), ribavirin, HPA23, AL 721, or phosphonoformate.

Patients with the following are excluded:

  • Evidence of nervous system dysfunction caused by factors other than HIV infection, including chronic alcohol or drug abuse. Present or prior known AIDS-defining opportunistic infections, lymphomas, or malignancies based on CDC criteria. Present or prior known systemic opportunistic diseases most recently included in the expanded CDC definition of AIDS:
  • extrapulmonary or disseminated Mycobacterium tuberculosis infections, recurrent nontyphoidal Salmonella septicemia, coccidioidomycosis, diffuse interstitial lymphoid pneumonitis.
  • Evidence of compromised bone marrow function defined by specified lab values. Evidence of HIV neurologic disease.
  • Evidence of HIV-associated wasting syndrome.
  • Hypersensitivity to retrovir.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Interferon.
  • Immunomodulating agents.
  • Myelosuppressive drugs.
  • Nephrotoxic agents.
  • Other experimental chemotherapy.

Prior Treatment:

Excluded:

  • Treatment with radiation therapy (with the exception of electron beam therapy to an area of less than 100 cm2).

Chronic alcohol or drug abuse.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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