Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002224

Enrollment

120

Registered

2001-08-31

Start date

1999-03-31

Completion date

1999-03-31

Last updated

2011-04-25

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

Conditions

HIV Infections

Keywords

Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Brief summary

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Detailed description

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Interventions

DRUGNelfinavir mesylate

DRUGStavudine

DRUGDidanosine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

You may be eligible for this study if you: * Are HIV-positive. * Are at least 18 years old. * Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion criteria

You will not be eligible for this study if you: * Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.) * Have severe diarrhea. * Are pregnant or breast-feeding. * Have a history of pancreatic disease or any other serious condition. * Have hepatitis within 30 days prior to study entry. * Cannot take medications by mouth. * Have received certain medications.

Countries

Canada, United States

Outcome results

None listed

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