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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001057 |
Purpose
To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3.
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Zidovudine Drug: Didanosine |
Phase II |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine Didanosine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3 |
| Estimated Enrollment: | 105 |
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 2 weeks prior to study entry:
Active substance abuse or alcoholism.
Contacts and Locations| United States, Minnesota | |||||
| Univ of Minnesota | |||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| St Paul Ramsey Med Ctr | |||||
| St Paul, Minnesota, United States, 55101 | |||||
| Hennepin County Med Clinic | |||||
| Minneapolis, Minnesota, United States, 55415 | |||||
| United States, Nebraska | |||||
| Univ of Nebraska Med Ctr | |||||
| Omaha, Nebraska, United States, 681985130 | |||||
| United States, Ohio | |||||
| Case Western Reserve Univ | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| United States, Pennsylvania | |||||
| Thomas Jefferson Univ Hosp | |||||
| Philadelphia, Pennsylvania, United States, 191075098 | |||||
| United States, Texas | |||||
| Univ of Texas Galveston | |||||
| Galveston, Texas, United States, 775550435 | |||||
| Study Chair: | Erice A | |
| Study Chair: | Balfour H | |
| Study Chair: | Carey J | |
| Study Chair: | Henry K | |
| Study Chair: | Hasse A |
More Information
Click here for more information about Zidovudine 
  |
Click here for more information about Didanosine 
  |
| Study ID Numbers: | ACTG 275 |
| First Received: | November 2, 1999 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001057 |
| Health Authority: | United States: Federal Government |
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