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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00000625
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: July 2000
• Target sample size: 2100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000625
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Puerto Rico, Tanzania, United States

Contacts

• Name: Hammer S

• Name: Katzenstein D

Key inclusion & exclusion criteria

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Didanosine

Drug: Zalcitabine

Drug: Zidovudine

Secondary ID(s)

11150

ACTG 175

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb

Glaxo Wellcome