A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000625

Enrollment

2100

Registered

2001-08-31

Start date

Unknown

Completion date

1995-11-30

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Zalcitabine, Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine

Brief summary

To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.

Detailed description

Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm. PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.

Interventions

DRUGZidovudine

DRUGZalcitabine

DRUGDidanosine

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Concurrent Medication: Allowed: * PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for \< 21 days, regularly prescribed medications, and vitamins or herbal therapies. Patients must have: * HIV infection without AIDS with CD4 200-500 cells/mm3. PER AMENDMENT 4/5/95: * Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible.

Exclusion criteria

Co-existing Condition: Patients with the following conditions are excluded: * Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy. Concurrent Medication: Excluded: * Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance. Concurrent Treatment: Excluded: * Radiotherapy other than limited local therapy to skin. Patients with the following prior conditions are excluded: * AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis. Prior Medication: Excluded: * Acute therapy for an infection or other medical illness within the past 14 days. Current alcohol abuse.

Countries

Puerto Rico, Tanzania, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026