Phase 4
Completed N=252
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
Source: ClinicalTrials.gov NCT00207142 ↗Enrolled (actual)
252
Serious AEs
9.1%
Results posted
Jan 2010
Primary outcomePrimary: Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase — 78; 75 Percentage of participants
Summary
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HIV-1 RNA <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase |
78; 75 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA <400 c/mL Through Week 48 of the Maintenance Phase |
86; 81 | — |
| SECONDARY Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase |
0.9655; 0.9412; 0.9655; 0.9176; 0.9540; 0.9059 | — |
| SECONDARY Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase |
0.9412; 0.9885; 0.9176; 0.9885; 0.9059; 0.9770 | — |
| SECONDARY Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase |
100; 92 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase |
170; 201; 177 | — |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase |
313 | — |
| SECONDARY Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase |
-3.16; -3.35; -3.21 | — |
| SECONDARY Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase |
-3.71 | — |
| SECONDARY Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase |
29; 7; 8; 6 | — |
| SECONDARY Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase |
39; 2; 9; 0 | — |
| SECONDARY Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase |
131; 3; 171; 5; 172; 31 | — |
| SECONDARY Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase |
168; 39; 171; 54; 172; 55 | — |
| SECONDARY Summary of Adverse Events During Induction Phase |
0; 3; 3; 7; 9; 16 | — |
| SECONDARY Summary of Adverse Events During Maintenance Phase |
0; 0; 4; 3; 0; 0 | — |
| SECONDARY Summary of Adverse Events During Rescue Phase |
1; 2; 0; 1 | — |
| SECONDARY Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase |
-4.7; 1.4; 3.7; 0.8; -0.7; -2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
- Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
- Subjects who have a CD4 count ≥ 50 cells/mm3.
- Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
- Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives
Exclusion Criteria
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
- Primary HIV infection
- Medical History and Concurrent Diseases
- Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
- Screening laboratory values measured as follows:
- Grade IV glucose,
- Grade IV electrolytes,
- Grade IV transaminases,
- Grade IV hematology.
- Hypersensitivity to any component of the formulation of study drug
- Prior history of taking any ARV for more than 10 days
- Concomitant administration of tenofovir (TDF).
- Refer to Section 6.4.1 which details all prohibited therapies
Data sourced from ClinicalTrials.gov (NCT00207142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.